tag:blogger.com,1999:blog-29371171227880517532024-02-18T19:07:45.018-08:00Genelife Clinical Research Private Limited Your Trustworthy Partner In Product DevelopmentGenelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.comBlogger41125tag:blogger.com,1999:blog-2937117122788051753.post-54859831426459018412023-10-31T23:17:00.007-07:002023-10-31T23:17:47.906-07:00Embarking on a Holistic Approach to Drug Development with Genelife Clinical Research<p style="text-align: justify;"><br /></p><p class="ember-view reader-content-blocks__paragraph" id="ember1353" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"> <span style="font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large);">In the ever-evolving realm of pharmaceutical development, the journey from concept to market is a complex odyssey. Genelife Clinical Research, a distinguished Contract Research Organization (CRO), is committed to being your guiding light through every twist and turn of this intricate path. We offer a holistic approach to drug development that encompasses every facet of this journey, driven by expertise, innovation, and a comprehensive outlook.</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1353" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Beyond Service: Your Dedicated Collaborator</b></p><p class="ember-view reader-content-blocks__paragraph" id="ember1353" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihopXYwBMtvYfg7liR9Tt9M5NHI9aDPDxMxwhSgsJoPSdh9ZrGvNAhJBlul9gt5Fm8ZWwkVk0sJ46wPl60EDvl62rUy9lbAOzO2ndySMfroCmwRIIDgkr0YAaTHzAN42bfi3Nke5E02SGLywzEOP_rQCsgS84BRN896BS2PXWyQ2mGdK0BVLEHJ2m-tq9K/s699/1698313603543.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="390" data-original-width="699" height="179" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihopXYwBMtvYfg7liR9Tt9M5NHI9aDPDxMxwhSgsJoPSdh9ZrGvNAhJBlul9gt5Fm8ZWwkVk0sJ46wPl60EDvl62rUy9lbAOzO2ndySMfroCmwRIIDgkr0YAaTHzAN42bfi3Nke5E02SGLywzEOP_rQCsgS84BRN896BS2PXWyQ2mGdK0BVLEHJ2m-tq9K/s320/1698313603543.png" width="320" /></a></div>At the core of Genelife Clinical Research's philosophy is the belief that we should be more than just a service provider; we strive to be your dedicated collaborator. We understand that the world of pharmaceuticals demands a multidimensional approach, and we have the knowledge and resources to meet those demands. Our services cover the entire spectrum of drug development, including discovery, pre-clinical phases, bioavailability and bioequivalence (BA/BE) studies, clinical trials, regulatory approvals, and beyond. Our holistic approach is built upon a foundation of collaboration, innovation, and unwavering dedication.<p></p><p class="ember-view reader-content-blocks__paragraph" id="ember1354" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Integrated Solutions for a Complex Landscape</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1355" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">The drug development landscape is multifaceted and perpetually evolving. Our holistic approach ensures that no aspect is overlooked. From the early phases of development, including animal studies, to pivotal clinical trials and regulatory submissions, we offer integrated solutions that address challenges at every stage. Genelife Clinical Research boasts both Good Laboratory Practice (GLP) and Non-GLP facilities for pre-clinical studies. Furthermore, we've developed various disease models for optimizing medical devices and medicinal products. Our BA/BE facilities span India, the Middle East, and Europe, and we're actively conducting clinical studies on a global scale. By harmonizing scientific insights with operational excellence, we expedite timelines and enhance the overall efficiency of the development process.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1356" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Innovative Solutions for Unprecedented Challenges</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1357" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">The drug development landscape is ever-evolving, marked by continuous advancements in science and technology. Genelife Clinical Research stays at the forefront of innovation, integrating cutting-edge technology, data-driven insights, and industry best practices into our services. This ensures that our partners receive not only conventional support but also innovative solutions that can streamline their drug development process.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1358" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Expertise Across Diverse Therapeutic Areas</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1359" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Our extensive experience extends across a wide range of therapeutic areas, encompassing oncology, cardiovascular, central nervous system (CNS), dermatology, gastroenterology, ophthalmology, and more. This diverse expertise enables us to address the unique challenges and requirements of different disease areas effectively. We believe in offering tailored solutions that resonate with the specific needs of each project.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1360" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Global Reach and Collaborative Excellence</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1361" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">With a global presence in Europe, the USA, UK, India, and Singapore, along with collaborations in China, Australia, and South Africa, Genelife Clinical Research offers a truly global reach. We can seamlessly cater to both regional and international clinical research needs, adapting to the diverse regulatory environments present worldwide. Our network of collaborative partners enhances the quality and effectiveness of our services.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1362" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Navigating Complex Regulatory Landscapes</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1363" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Regulatory compliance is a critical component of drug development. Genelife Clinical Research has a proven track record of skillfully navigating the complex regulatory landscapes governing pharmaceuticals. Our long-standing relationships with regulatory consultants facilitate a smooth and expedited regulatory approval process, ensuring our partners can approach these regulatory challenges with confidence and efficiency.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1364" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Transparent and Real-Time Project Monitoring</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1365" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Communication and transparency are paramount in any successful partnership. Genelife Clinical Research provides real-time project development tracking, eliminating the need for constant communication with the CRO for minor updates. This not only saves time and effort but also enhances project management efficiency.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1366" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Comprehensive Services for a Simplified Journey</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1367" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Our holistic approach ensures that all aspects of the drug development journey are addressed. We provide an extensive suite of clinical research services, including project management, site selection and management, data management, biostatistics, medical writing, regulatory consulting, pharmacovigilance services, and more. This full-service approach simplifies the clinical trial process for our clients, streamlining the path to successful drug development.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1368" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>High Ethical Standards for Patient Well-Being</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1369" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">At Genelife Clinical Research, we uphold high ethical standards in all our operations. Patient safety and well-being are non-negotiable, reflecting our unwavering commitment to the values of healthcare and the welfare of all clinical trial participants.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1370" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Tailored Solutions for Success</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1371" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">We understand that each drug development project is unique. Our dedicated team collaborates closely with sponsors to develop custom strategies that drive successful outcomes. Our commitment is to be your partner in realizing your vision for innovative therapies.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1372" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b><br />Partnering for Success</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1373" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Genelife Clinical Research is more than a service provider – we are your collaborative partner on the road to success. Our holistic approach is founded on open communication, mutual understanding, and shared goals. By seamlessly integrating diverse elements of drug development, we empower you to bring impactful treatments to patients while achieving your business objectives.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1374" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Our Unique Selling Proposition (USP)</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1375" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Genelife Clinical Research Private Limited stands out in the clinical research landscape due to its commitment to innovation, global reach, regulatory expertise, transparency, and comprehensive services. Our USP lies in our ability to provide tailored solutions that advance clinical trials efficiently and effectively. With Genelife, you're not just a partner; you're a collaborator in bringing groundbreaking pharmaceuticals to the world, making a positive impact on the healthcare industry and patients' lives.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-44380336418807329372023-10-28T11:34:00.004-07:002023-10-28T11:36:05.734-07:00Navigating the Complexity of Medical Device Clinical Trials: Genelife's Expertise<p style="text-align: justify;"> <span color="rgba(0, 0, 0, 0.9)" face="-apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif" style="caret-color: rgba(0, 0, 0, 0.9); font-size: var(--font-size-large);">In the realm of clinical research, medical devices constitute a diverse and critical category. At Genelife Clinical Research, we bring our extensive experience and unwavering commitment to excellence to the forefront in the conduct of medical device and drug-device combination clinical trials.</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1147" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgdMxpjYSpH2Qp0zeuzmxmw9_oShK4t_t41-MnJ3sCjLiR-CPE0FhRHTnxn9xKIt0yLFtpuP-IzX4M_TpvuYMjCDhkCHWkZYWM-CnBYDNYJa7xvVm75gDGkTmitX9qTxHNrgwfko2e94O7PqBE3POMo4uZGyDe_s1WWvbvPpK8JSX9XbxyY3j6Q-Tf0WXEx/s800/1697349724249.jpeg" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="440" data-original-width="800" height="228" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgdMxpjYSpH2Qp0zeuzmxmw9_oShK4t_t41-MnJ3sCjLiR-CPE0FhRHTnxn9xKIt0yLFtpuP-IzX4M_TpvuYMjCDhkCHWkZYWM-CnBYDNYJa7xvVm75gDGkTmitX9qTxHNrgwfko2e94O7PqBE3POMo4uZGyDe_s1WWvbvPpK8JSX9XbxyY3j6Q-Tf0WXEx/w415-h228/1697349724249.jpeg" width="415" /></a></div><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Four Main Categories of Medical Devices</span><p></p><p class="ember-view reader-content-blocks__paragraph" id="ember1148" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">From a clinical research perspective, medical devices span a spectrum of functions, and we classify them into four main categories:</p><p class="ember-view reader-content-blocks__paragraph" id="ember1149" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"></p><ol style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text); font-size: var(--font-size-large); line-height: 1.75; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><li style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: 0.8rem 0px 0.8rem 3.2rem; padding-left: 0.8rem; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Therapeutic Devices:</span><span class="Apple-converted-space"> </span>These can be either active (e.g., implantable cardiac devices) or inactive (e.g., bandages). Their primary purpose is to treat or alleviate medical conditions.</li><li style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: 0.8rem 0px 0.8rem 3.2rem; padding-left: 0.8rem; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Non-Therapeutic, Non-Diagnostic (Accessory) Devices:</span><span class="Apple-converted-space"> </span>These encompass accessories and components that support the functioning of other medical devices, such as connectors or tubing.</li><li style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: 0.8rem 0px 0.8rem 3.2rem; padding-left: 0.8rem; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Diagnostic Devices:</span><span class="Apple-converted-space"> </span>Diagnostic medical devices are crucial for the accurate diagnosis of medical conditions, from blood glucose monitors to imaging equipment.</li><li style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: 0.8rem 0px 0.8rem 3.2rem; padding-left: 0.8rem; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Contraceptive Devices:</span><span class="Apple-converted-space"> </span>Devices designed to prevent pregnancy, like intrauterine devices (IUDs), fall into this category.</li></ol><p></p><p class="ember-view reader-content-blocks__paragraph" id="ember1150" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">The Complexity of Medical Device Clinical Trials</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1151" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Medical device clinical trials present unique complexities compared to drug trials. One of the key challenges is the absence of a perfect control group, making study design pivotal in overcoming these constraints. Furthermore, the concept of "absolute safety and efficacy" is elusive in medical device trials, as experimentation on healthy human subjects rarely provides definitive answers. Instead, outcomes tend to be study-specific, limiting their direct applicability to the real world.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1152" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Innovative Study Designs for Medical Devices</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1153" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">To address these challenges, Genelife Clinical Research employs innovative study designs tailored to the nuances of medical device trials. Two crucial postulates guide our approach:</p><p class="ember-view reader-content-blocks__paragraph" id="ember1154" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"></p><ol style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text); font-size: var(--font-size-large); line-height: 1.75; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><li style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: 0.8rem 0px 0.8rem 3.2rem; padding-left: 0.8rem; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Variation of the Hypothesis:</span><span class="Apple-converted-space"> </span>In many medical device clinical trials, we structure the study hypothesis to specifically test particular outcomes. This tailored approach ensures the relevance and effectiveness of the study.</li><li style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: 0.8rem 0px 0.8rem 3.2rem; padding-left: 0.8rem; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Inclusion of Subsets:</span><span class="Apple-converted-space"> </span>Exclusion of subsets of the population can lead to results that do not align with real-world scenarios. Therefore, we proactively include predetermined subsets in our study designs, enhancing the study's applicability and statistical power.</li></ol><p></p><p class="ember-view reader-content-blocks__paragraph" id="ember1155" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Navigating Regulatory Requirements with Expertise</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1156" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Genelife Clinical Research possesses the expertise to assist clients in navigating the complex regulatory landscape of medical devices. We are well-versed in the submission of Investigational Device Exemptions (IDE) and 510(k) premarket notifications.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1157" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Moreover, we assist our clients in integrating various medical device regulatory requirements into their quality management systems, including ISO 13485, 21CFR820, Canadian Medical Devices Conformity Assessment (CMDCAS), and the Medical Device Directive (MDD). This comprehensive approach ensures that our clients' quality management systems are not only compliant but also scalable to meet the global requirements for medical device market approval and distribution.</p><br /><p></p><p class="ember-view reader-content-blocks__paragraph" id="ember1158" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">At Genelife Clinical Research, we recognize the intricacies of medical device trials and have positioned ourselves as a trusted partner for those seeking to navigate this complex terrain. Our commitment to innovation, ethical conduct, and excellence ensures that we provide high-quality outcomes in the ever-evolving field of medical device clinical research.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-79119163949781134382023-10-24T22:43:00.000-07:002023-10-24T22:43:22.261-07:00Genelife: Excellence in Cosmetic Development Programs<p style="text-align: justify;"><span style="caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large);">In the ever-evolving landscape of cosmetology and dermatological products, rigorous </span><span style="caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large);">clinical research is the cornerstone of ensuring the safety and efficacy of skincare solutions. Genelife Clinical Research, a dynamic Clinical Research Organization (CRO), has emerged as a trailblazer in this field, spearheading groundbreaking cosmetology clinical </span><span style="caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large);">trials and non-clinical studies. With over a decade of experience and an unwavering commitment to quality, Genelife is at the forefront of innovation, driving advancements in skincare and aesthetics.</span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiDr36ixuSG5tlQKILCj0PnvUx70wD1yL2vORAqy53SJj_mSJT-yxxBTl9C-7A_wOZoLzz5evv7I8r4Y6oF1qo6BCWblRTgL7jGNBdhZgo8nF02tNISN-CgJ0gT42U2BnFAVu2UxC0BmKeW25nZXLy9MetXxU7_ZJkaoTGG5PPFwHINk9Aw9UdemYbRFr8S/s746/1696965358488.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="423" data-original-width="746" height="232" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiDr36ixuSG5tlQKILCj0PnvUx70wD1yL2vORAqy53SJj_mSJT-yxxBTl9C-7A_wOZoLzz5evv7I8r4Y6oF1qo6BCWblRTgL7jGNBdhZgo8nF02tNISN-CgJ0gT42U2BnFAVu2UxC0BmKeW25nZXLy9MetXxU7_ZJkaoTGG5PPFwHINk9Aw9UdemYbRFr8S/w410-h232/1696965358488.png" width="410" /></a></div><br /><p></p><p><span style="caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--artdeco-reset-base-font-size-hundred-percent);"><b>A Comprehensive Portfolio of Services</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1211" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Genelife's extensive portfolio of services encompasses a wide array of cosmetic development programs, including:</p><p class="ember-view reader-content-blocks__paragraph" id="ember1212" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Clinical Research Services:</b></span><span class="Apple-converted-space"> </span>Genelife Clinical Research has extensive experience in performing medicinal dermatology products regulated as well as non-regulated clinical studies for claim substantiation with clinical proof.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1213" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Regulated Dermatology Studies:</b></span><span class="Apple-converted-space"> </span>The company has successfully conducted regulated dermatology studies, including 505(b)(2) studies for conditions such as Ichthyosis and Psoriasis. These studies are pivotal in obtaining approvals from regulatory bodies like the US FDA, Therapeutic Goods Administration (TGA), and CDSCO.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1214" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Proof of Concept Clinical Studies:</b></span><span class="Apple-converted-space"> </span>Genelife offers customized proof of concept clinical studies for cosmetology. These studies provide clients with clinically proven results, substantiating their product claims at an affordable cost. We have performed studies covering Skin Care Studies, fairness studies, Sunblock studies (SPF), Aesthetic and Anti-Aging, Hair Care and Restoration, oral and dental care studies, mosquito repellent, perfume studies, and studies for room & car fresheners.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1215" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Non-Clinical Studies:</b></span><span class="Apple-converted-space"> </span>Genelife conducts vital non-clinical studies, including Acute Dermal Toxicity in rats and rabbits, Acute Mucus Membrane toxicity study, Primary Skin Irritation test, AMES test, Micronucleus test, Chromosomal Aberration test- in vivo, Chromosomal Aberration test in vitro, to assess product safety, toxicology, and performance. These studies play a crucial role in the development of cosmetic products.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1216" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Navigating Complex Regulatory Landscapes</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1217" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">One of Genelife's core strengths lies in its adeptness at navigating the complex regulatory landscape governing cosmetics and dermatological products. The company ensures that all studies adhere to the highest regulatory standards, facilitating the approval process. This expertise extends to various regulatory bodies, including the US FDA, TGA, and CDSCO.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1218" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Global Reach and Customized Solutions</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1219" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">With a global presence that spans Europe, the USA, UK, India, and Singapore, Genelife conducts cosmetology studies on an international scale. This global reach enables the company to serve clients worldwide, adapting to diverse regulatory environments.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1219" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); text-align: left;">Genelife recognizes that each cosmetology study is unique. The company's approach is tailored to meet the specific needs of each project, whether it involves designing a clinical trial or conducting non-clinical testing. Solutions are customized for optimal results, ensuring that the highest standards of quality and safety are met.</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1221" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Commitment to Excellence</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember1222" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Genelife Clinical Research's commitment to excellence is unwavering. With a team of experienced and customer-centric professionals, the company guarantees the best service. Genelife's mission is to provide solutions for the twin challenges of timeline and quality in clinical development programs. The utmost concern is the satisfaction of sponsors, reflecting a dedication to delivering extraordinary global service.</p><p class="ember-view reader-content-blocks__paragraph" id="ember1223" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; text-align: justify; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">In conclusion</span>, Genelife Clinical Research stands as a beacon of innovation and quality in the realm of cosmetology clinical trials and non-clinical studies. Their ability to navigate regulatory landscapes, offer customized solutions, and provide global reach positions them as a trusted partner in the development of safe and effective cosmetic products. Genelife's dedication to excellence ensures that they continue to contribute to the advancement of the cosmetology field.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-71398488604669731482023-10-04T01:49:00.000-07:002023-10-04T01:49:06.151-07:00 Transforming Oncology Clinical Trials: The Genelife Model<p><span style="caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; white-space-collapse: preserve;">Millions of dollars are invested in the quest for groundbreaking cancer treatments. Yet, the exorbitant costs of cancer treatment stem not only from research and development but also from the protracted timelines involved in clinical trials. Recognizing this challenge, Genelife Clinical Research has pioneered a revolutionary model designed to streamline oncology clinical trials. This innovative approach leverages disease surveillance data and an in-depth analysis of cancer study trends to significantly reduce trial timelines and costs, all while maintaining the highest standards of quality.</span></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">The Challenge in Oncology Clinical Trials</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;">The landscape of oncology clinical trials is riddled with complexities, from prolonged and ethically questionable early stages to frequent failures in the initial phases. Study design-related issues, such as ambiguous endpoints and criteria, pose additional hurdles. General acceptance of study reports and the enduring problem of lengthy timelines—due to factors like low recruitment rates, Investigational New Drug (IND) complications, multiplicity of effects, and low patient survival rates—further compound the challenge.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEizQw3rWyTFJV4J3Qb9V8RqHvYznTi8eEDihayuaHuG9Il5myInpRsqjF0Ew_egGvv5MK2h-nM0FNORXAQVZskDU2kd3vWKK-IS1KFg-zj54YFuAf_q394QLDFMrH7nk_0sLu2uMjfHY95qiIlbLDDRXMNxRrX5LhDg7ssYIW1OoxwyGs4cPMkvFDvzphQv/s1048/238898684_4349752901738829_1722014076865469883_n.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="504" data-original-width="1048" height="179" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEizQw3rWyTFJV4J3Qb9V8RqHvYznTi8eEDihayuaHuG9Il5myInpRsqjF0Ew_egGvv5MK2h-nM0FNORXAQVZskDU2kd3vWKK-IS1KFg-zj54YFuAf_q394QLDFMrH7nk_0sLu2uMjfHY95qiIlbLDDRXMNxRrX5LhDg7ssYIW1OoxwyGs4cPMkvFDvzphQv/w372-h179/238898684_4349752901738829_1722014076865469883_n.png" width="372" /></a></div><br /><p></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">The Genelife Model: A Paradigm Shift</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;">The Genelife model stands as a pioneering effort to address these challenges by focusing on precise inputs, meticulous processes, and optimal outputs. At its core, this model emphasizes the critical role of inputs provided by both Genelife Clinical Research and the Sponsor. For sponsors seeking to expedite trials, embracing modern approaches like Phase 0 and novel Phase I designs is pivotal. A critical aspect is the simplification of inclusion and exclusion criteria, considering the intricate nature of oncology studies.</p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">Strategic Site Selection</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;">Site selection becomes a crucial decision, necessitating sites with high disease prevalence, experienced investigators, and favorable regulatory environments. In cases where Genelife Clinical Research encounters expertise gaps, they play a guiding role and assist sub-CROs or SMOs in identifying the right partners with robust patient and knowledge bases in line with industry trends. Genelife contributes invaluable insights through innovative research methodologies, including translational research, meticulous site selection, and feasibility assessments.</p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">Efficiency through Accurate Inputs</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;">Efficiency in clinical trial processes is underpinned by accurate inputs and adherence to well-defined SOPs, alongside the training of monitors. Genelife Clinical Research bears the responsibility of empathizing with site personnel and patient volunteers, catering to their clinical study needs. Robust systems for patient follow-up and IP administration are integral components. Site effectiveness is paramount for conducting high-quality trials, including 100% source data verification.</p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">Comprehensive Support</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;">Hospital/site support plays a pivotal role in the entire process, encompassing comprehensive site-based assistance and the recruitment of ICH – GCP trained staff. Raising awareness and marketing clinical trials are also integral steps, aimed at accelerating subject recruitment, ensuring data quality, fostering a favorable regulatory environment, and enhancing the understanding of clinical trials among physicians and patients. These efforts are long-term endeavors that require consistent dedication. Genelife Clinical Research often conducts disease prevalence studies to gauge the extent of disease prevalence and maintains databases of primary health centers and general physicians, actively promoting clinical research to garner their support in volunteer recruitment—an indispensable aspect of oncology studies.</p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">The Path to Success</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;">The ultimate success of this comprehensive model hinges on precise inputs and efficient processes. According to the Genelife model, this meticulous approach yields desired outcomes, including expedited regulatory approvals, high-quality data, shortened trial timelines, and improved return on investment.</p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px; text-size-adjust: auto; white-space-collapse: preserve;"><strong class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; color: var(--tw-prose-bold);">Meeting the Demands of a Changing Industry</strong></p><p class="" style="--tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-ring-color: rgba(69,89,164,0.5); --tw-ring-offset-color: #fff; --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-offset-width: 0px; --tw-ring-shadow: 0 0 transparent; --tw-rotate: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-scroll-snap-strictness: proximity; --tw-shadow-colored: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-skew-x: 0; --tw-skew-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; border: 0px solid rgb(217, 217, 227); box-sizing: border-box; caret-color: rgb(55, 65, 81); color: #374151; font-family: Söhne, ui-sans-serif, system-ui, -apple-system, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, "Helvetica Neue", Arial, "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Noto Color Emoji"; font-size: 16px; margin: 1.25em 0px 0px; text-size-adjust: auto; white-space-collapse: preserve;">In an era demanding quality data in the most cost-effective manner, the Genelife model emerges as a transformative solution. As industry dynamics shift due to economic considerations, cost-effective research becomes paramount, and CROs emerge as invaluable partners in this quest. Our model encapsulates a blueprint for reducing the timeline of oncology clinical trials, offering hope to millions of patients awaiting breakthrough treatments. Genelife Clinical Research is at the forefront of this transformation, paving the way for a brighter future in cancer research.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-82242309280620832122023-09-30T15:00:00.002-07:002023-10-01T09:59:32.254-07:00Patient-Centric Focus: Elevating Clinical Trials Worldwide<p> <span color="rgba(0, 0, 0, 0.9)" face="-apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif" style="caret-color: rgba(0, 0, 0, 0.9); font-size: var(--font-size-large);">In the realm of clinical research, the pivotal role of patients cannot be overstated. The success of clinical trials hinges on not only recruiting a diverse patient population but also retaining their participation throughout the study. At Genelife Clinical Research, we recognize the profound significance of patient recruitment and retention, and we've pioneered a unique approach that caters to the needs of patients across different regions. Our commitment to patient-ce</span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiDV9OMVC_V-7c0a_sXMAYaCLPAEhpS47N5oJSFay7wabHBcqypDujmopOUgeBIk_lDgEm22lPsA4db-23lSeuPNORdTj-qnvPXeWNyfumNhlXX7uPQHH6RiJb8YK92pHiSgHKtXtXajElDamx2AnwKH2HiKo3vq3gcOlHSAqGPs6DXC8DRWJ-_UI4gtWwb/s669/Screenshot%202023-10-01%20at%203.14.42%20AM.png" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="324" data-original-width="669" height="155" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiDV9OMVC_V-7c0a_sXMAYaCLPAEhpS47N5oJSFay7wabHBcqypDujmopOUgeBIk_lDgEm22lPsA4db-23lSeuPNORdTj-qnvPXeWNyfumNhlXX7uPQHH6RiJb8YK92pHiSgHKtXtXajElDamx2AnwKH2HiKo3vq3gcOlHSAqGPs6DXC8DRWJ-_UI4gtWwb/s320/Screenshot%202023-10-01%20at%203.14.42%20AM.png" width="320" /></a></div><br />ntricity remains unwavering, irrespective of geographical boundaries.<p></p><p class="ember-view reader-content-blocks__paragraph" id="ember283" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">The Global Challenge of Patient Recruitment and Retention</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember284" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Patient recruitment and retention have long been recognized as significant challenges in the clinical research landscape. Ensuring that clinical trials are conducted with a diverse participant base that accurately represents the target patient population is essential for generating robust, applicable data. Likewise, retaining patients throughout the trial's duration is crucial for obtaining meaningful insights into treatment effectiveness and safety.</p><p class="ember-view reader-content-blocks__paragraph" id="ember285" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Our Patient-Centric Approach</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember286" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">1. Tailored Engagement:</span><span class="Apple-converted-space"> </span>We understand that patients from different regions may have unique needs, concerns, and preferences. Our approach involves tailoring patient engagement strategies to accommodate these differences effectively. By acknowledging and addressing these distinctions, we create a more comfortable and supportive environment for trial participants.</p><p class="ember-view reader-content-blocks__paragraph" id="ember287" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">2. Multilingual Support:</span><span class="Apple-converted-space"> </span>Language barriers should never be a hindrance to patient participation. Our global presence ensures that we can provide multilingual support to patients, eliminating communication challenges. This inclusivity fosters trust and ensures that patients fully comprehend their roles in the trial.</p><p class="ember-view reader-content-blocks__paragraph" id="ember288" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">3. Cultural Sensitivity:</span><span class="Apple-converted-space"> </span>Cultural factors can significantly impact a patient's willingness to participate in a clinical trial. Our teams in different regions are trained to be culturally sensitive and respectful of local customs. This cultural competence helps in building rapport with patients, fostering a sense of trust and cooperation.</p><p class="ember-view reader-content-blocks__paragraph" id="ember289" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">4. Localized Convenience:</span><span class="Apple-converted-space"> </span>We strive to make participation in clinical trials as convenient as possible for patients. This involves offering flexible scheduling options, ensuring easy access to trial sites, and addressing logistical concerns that may vary from region to region. By removing logistical obstacles, we enhance patient retention rates.</p><p class="ember-view reader-content-blocks__paragraph" id="ember290" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">5. Continuous Support:</span><span class="Apple-converted-space"> </span>The patient's journey through a clinical trial can be challenging. Our commitment to patient-centricity means that we provide continuous support, not just during the trial but also afterward. This support extends to addressing any post-trial medical needs or questions, ensuring that patients feel valued and cared for.</p><p class="ember-view reader-content-blocks__paragraph" id="ember291" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Advancing Clinical Research Through Patient-Centricity</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember292" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">At Genelife Clinical Research,<span class="Apple-converted-space"> </span><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">we firmly believe that patient-centricity is not just a buzzword but a fundamental principle that drives the success of clinical trials.</span><span class="Apple-converted-space"> </span>Our global approach ensures that this principle remains at the forefront of everything we do. By recognizing and embracing the diversity of patients and their unique needs, we contribute to the advancement of clinical research on a global scale.</p><p class="ember-view reader-content-blocks__paragraph" id="ember293" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">In conclusion, our patient-centric focus transcends geographical boundaries. It's a commitment to ensuring that patients, regardless of where they come from, receive the care, respect, and support they deserve as vital contributors to the progress of medical science. </p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-47728770900262262102023-09-27T01:55:00.000-07:002023-09-27T01:55:01.242-07:00Quality at Genelife Clinical Research<p> <span style="caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large);">Quality is the cornerstone of excellence in clinical research. At Genelife Clinical Research, our unwavering commitment to quality is at the heart of everything we do. In an industry where precision and integrity are paramount, we've set the bar high and continue to raise it. Below is a brief overview of how we prioritize and ensure quality at every stage of our clinical research endeavors.</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember459" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>The Quality Assurance Framework</b></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjvFLMr8IEOrAUl3ZMHTpsGi8EFdxU_iHPxrUdt0Vm6zEMZeqtskSgDXi6i8yrQjXDqEPNY9AJ8EqTJi2aOB0-SrtOjVt_1wA46zTivNX7CT9r5Avi2GBnc3GrSonlppOhkQjOZbf1snb26VSGStPVZQU1De8nklSbvn2-aHcVPN7sJqDTg-4y0fWhcMjbs/s775/Screenshot%202023-08-24%20at%203.57.20%20PM.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="428" data-original-width="775" height="177" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjvFLMr8IEOrAUl3ZMHTpsGi8EFdxU_iHPxrUdt0Vm6zEMZeqtskSgDXi6i8yrQjXDqEPNY9AJ8EqTJi2aOB0-SrtOjVt_1wA46zTivNX7CT9r5Avi2GBnc3GrSonlppOhkQjOZbf1snb26VSGStPVZQU1De8nklSbvn2-aHcVPN7sJqDTg-4y0fWhcMjbs/s320/Screenshot%202023-08-24%20at%203.57.20%20PM.png" width="320" /></a><b></b></div><p class="ember-view reader-content-blocks__paragraph" id="ember460" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Quality assurance isn't a one-time event; it's an integrated, ongoing process. Our comprehensive quality assurance framework is designed to:</p><p class="ember-view reader-content-blocks__paragraph" id="ember461" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Globally Acceptable SOP and Adherence:<span class="Apple-converted-space"> </span></b></span>Genelife Clinical Research places a strong emphasis on globally acceptable SOPs and their unwavering adherence as a cornerstone of our commitment to quality in clinical research.</p><p class="ember-view reader-content-blocks__paragraph" id="ember462" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Stringent Protocol Adherence:<span class="Apple-converted-space"> </span></b></span>We start by meticulously crafting research protocols that adhere to the highest scientific and ethical standards. These protocols serve as the foundation of our studies.</p><p class="ember-view reader-content-blocks__paragraph" id="ember463" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Rigorous Site Selection:</b></span><span class="Apple-converted-space"> </span>The selection of research sites is a critical step. Our quality assurance team conducts thorough evaluations to choose sites with a track record of excellence in research conduct.</p><p class="ember-view reader-content-blocks__paragraph" id="ember464" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Continuous Training:</span><span class="Apple-converted-space"> </span></b>Training is a continuous process. We invest in the professional development of our research teams, ensuring they remain up-to-date with the latest methodologies and regulations.</p><p class="ember-view reader-content-blocks__paragraph" id="ember465" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Data Integrity:</span><span class="Apple-converted-space"> </span></b>Maintaining the integrity of clinical data is non-negotiable. We employ advanced data management systems and stringent data monitoring processes to guarantee data accuracy and consistency.</p><p class="ember-view reader-content-blocks__paragraph" id="ember466" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Regulatory Compliance:</b></span><span class="Apple-converted-space"> </span>Staying compliant with local and international regulations is a top priority. Our regulatory affairs experts navigate the complex landscape of approvals and ensure that our studies meet all legal requirements.</p><p class="ember-view reader-content-blocks__paragraph" id="ember467" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Patient-Centric Quality:</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember468" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">We believe that Quality in clinical research isn't just about protocols and data; it's also about the patients who participate. We believe in a patient-centric approach to quality, which means:</p><p class="ember-view reader-content-blocks__paragraph" id="ember469" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Informed Consent:</b></span><span class="Apple-converted-space"> </span>We prioritize informed consent, ensuring that patients fully understand their participation, rights, and potential risks.</p><p class="ember-view reader-content-blocks__paragraph" id="ember470" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Patient Support:</b></span><span class="Apple-converted-space"> </span>We offer continuous support to trial participants, addressing their concerns, needs, and questions promptly.</p><p class="ember-view reader-content-blocks__paragraph" id="ember471" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Safety First:</b></span><span class="Apple-converted-space"> </span>Patient safety is paramount. We have robust safety monitoring systems in place to detect and address any adverse events promptly.</p><p class="ember-view reader-content-blocks__paragraph" id="ember472" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Transparency and Accountability:</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember473" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Quality thrives in an environment of transparency and accountability. We maintain open communication with all stakeholders, from sponsors to regulatory bodies. Our commitment to accountability means that we take responsibility for our actions and decisions throughout the research process.</p><p class="ember-view reader-content-blocks__paragraph" id="ember474" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Continuous Improvement:</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember475" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">We recognize that quality is a journey, not a destination. Therefore, we continually seek ways to enhance our processes, technologies, and methodologies. Regular quality audits, feedback mechanisms, and performance evaluations are integral to our commitment to improvement.</p><p class="ember-view reader-content-blocks__paragraph" id="ember476" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>In the realm of clinical research, quality is not negotiable;</b></span><span class="Apple-converted-space"> </span>it's the bedrock upon which scientific advancements are built. At Genelife Clinical Research, our pursuit of quality is unyielding. By prioritizing quality at every step, embracing a patient-centric approach, and fostering transparency and accountability, we contribute to the collective effort to advance medical knowledge and improve patient lives.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-2521650613510109182023-09-23T01:23:00.002-07:002023-09-23T01:23:44.193-07:00Global Presence: Bridging Continents in Clinical Research<p> <span style="caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large);">At Genelife Clinical Research, our commitment to excellence knows no borders. With a strong and dynamic global presence, we are strategically positioned to provide comprehensive clinical research solutions that transcend geographical boundaries. Having a direct presence in key regions, including India, Europe, the USA, and the UK, positions Genelife Clinical Research Pvt. Ltd. in a unique position to deliver patient-focused early phase and late phase clinical trials on a global scale, all while providing a localized touch. This strategic approach allows us to leverage our diverse expertise while adapting to regional nuances. As a result, we ensure that our comprehensive clinical trials services align with the specific needs and regulatory requirements of each region while maintaining a steadfast commitment to the broader market value. This blend of global reach and local expertise empowers us to provide customized solutions that consistently meet the highest standards of quality and compliance in the field of clinical research.</span></p><p class="ember-view reader-content-blocks__paragraph" id="ember466" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Why Our Global Presence Matters</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember467" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Local Expertise, Global Reach:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>With direct offices in diverse regions, we are equipped with local teams that possess in-depth knowledge of regional nuances, languages, and regulatory landscapes. This localized expertise is invaluable when navigating the intricacies of clinical research</p><p class="ember-view reader-content-blocks__paragraph" id="ember468" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Meeting Regional Needs:<span class="Apple-converted-space"> </span></b></span>Each region has its unique healthcare ecosystem, patient populations, and regulatory requirements. Our global presence ensures that we tailor our services to address these specific needs, ensuring compliance and efficiency.<span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--artdeco-reset-typography-font-weight-bold); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"> </span></p><p class="ember-view reader-content-blocks__paragraph" id="ember469" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Streamlined Communication:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>Being on the ground in multiple regions facilitates open and efficient communication with local stakeholders, including investigators, regulatory bodies, and patients. This seamless interaction enhances the success of our clinical trials.</p><p class="ember-view reader-content-blocks__paragraph" id="ember470" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Reduced Time to Market:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>Our ability to conduct trials across various continents streamlines the drug development process. This can significantly reduce time-to-market, allowing patients quicker access to innovative treatments.</p><p class="ember-view reader-content-blocks__paragraph" id="ember471" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Our Multifaceted Approach</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember472" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Strategic Collaborations:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>In addition to our direct presence, we have forged strategic collaborations in regions like China, Australia, and South Africa. These partnerships expand our capabilities and enable us to serve clients in even more diverse markets.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNRXf3QGxsVnsbNoIfHkM0waWdludwi4sLWzMS8FsjDRpRCA_v4Oq3dHqnCCB3Mw4sUBCkDJq4EqcZCrfnwy42wPHN8zCzAPpRk8pDw5jxsTb8j1bDt3hUi0P1XT7BZW7mP264YjI6i-9MPXYBb-P0DoQiThpc5bgebaY2KAL8BJe85g2h51yv9SLdxfOI/s765/Screenshot%202023-08-25%20at%205.31.47%20PM.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="425" data-original-width="765" height="178" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNRXf3QGxsVnsbNoIfHkM0waWdludwi4sLWzMS8FsjDRpRCA_v4Oq3dHqnCCB3Mw4sUBCkDJq4EqcZCrfnwy42wPHN8zCzAPpRk8pDw5jxsTb8j1bDt3hUi0P1XT7BZW7mP264YjI6i-9MPXYBb-P0DoQiThpc5bgebaY2KAL8BJe85g2h51yv9SLdxfOI/s320/Screenshot%202023-08-25%20at%205.31.47%20PM.png" width="320" /></a></div><br /><p></p><p class="ember-view reader-content-blocks__paragraph" id="ember473" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Regulatory Expertise:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>Getting regulatory approvals and complying local and global regulatory requirements are paramount in clinical research. Our teams in different regions are well-versed in local regulations, ensuring that trials are conducted with integrity and adherence to guidelines.</p><p class="ember-view reader-content-blocks__paragraph" id="ember474" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Quality Control:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>Maintaining the highest standards of quality is non-negotiable. Our global presence means that rigorous quality control measures are implemented consistently across all regions.</p><p class="ember-view reader-content-blocks__paragraph" id="ember475" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Patient-Centric Focus:</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>We understand the importance of patient recruitment and retention in clinical trials. So we have developed a unique method of catering the needs of patients in different regions. Our global approach ensures that patient-centricity remains at the forefront of our trials.</p><p class="ember-view reader-content-blocks__paragraph" id="ember476" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>The Genelife Advantage</b></span></p><p class="ember-view reader-content-blocks__paragraph" id="ember477" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span style="border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><b>Our global presence isn't just about having offices in multiple locations;</b><span class="Apple-converted-space" style="font-weight: var(--artdeco-reset-typography-font-weight-bold);"> </span></span>it's about a commitment to delivering excellence, maintaining compliance, and advancing clinical research on a global scale. By seamlessly integrating local expertise with our overarching dedication to quality, we offer clients the assurance of a trusted partner who can navigate the complexities of clinical research across borders.</p><p class="ember-view reader-content-blocks__paragraph" id="ember478" style="--artdeco-reset-typography_getfontsize: 1.6rem; --artdeco-reset-typography_getlineheight: 1.5; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; caret-color: rgba(0, 0, 0, 0.9); color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: var(--font-size-large); line-height: 1.75; margin: 1.6rem 0px; padding: var(--artdeco-reset-base-padding-zero); pointer-events: all; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Join us in our mission to transform healthcare through international collaboration, innovative solutions, and a truly global presence. Together, we're making a difference in the world of clinical research.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-39882324229319950102023-09-18T06:20:00.002-07:002023-09-18T06:20:21.400-07:00Empowering Innovation in Drug Discovery and Development: Genelife Clinical Research<p> <span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt; text-align: justify;">In the dynamic landscape of pharmaceuticals, medical devices, and biologics, the journey from drug discovery to market-ready products is marked by rigorous trials, precise data, and unwavering dedication. At Genelife Clinical Research, we stand as a trusted partner, facilitating this transformative journey for companies seeking excellence in clinical research.</span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Our Aim:</span></b><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Genelife Clinical Research is dedicated to supporting pharmaceutical, medical device, and biologics companies in the pursuit of breakthroughs that redefine healthcare. Our mission is clear: to provide cost-effective Phase I-IV clinical research services that not only reduce the timeline of clinical trials but also elevate the standards of precision and quality in the industry.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Tools of Success:</span></b><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">What sets us apart at Genelife is our commitment to achieving desired results through the "tools of success." These tools are the pillars upon which we build our approach to clinical research:</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Electronic Data Capture System: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">We harness the power of technology to streamline data collection, ensuring accuracy and efficiency in the clinical trial process. Our CDISC complaint electronic data capture system accelerates data management while minimizing errors, enabling faster database lock with proper audit trail.</span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQJaiT4FquAEe1IrDqLevRYjQOUnT-xWLKD_ECFynK79C-KD9ELxclAdae7oWRbYxg4MdgkfNEwjL8Tob7pnNlKbpiFnV3V0EIEbJ1U2sglIXVro5VqruSmK21dwTqHoeAoilEsINDZczmYs_oDhuhQRoID7hZs5zTguBj0nYgfBEtW-IkJ9N1pNtDiEtS/s800/1693894979100.jpeg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="489" data-original-width="800" height="245" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQJaiT4FquAEe1IrDqLevRYjQOUnT-xWLKD_ECFynK79C-KD9ELxclAdae7oWRbYxg4MdgkfNEwjL8Tob7pnNlKbpiFnV3V0EIEbJ1U2sglIXVro5VqruSmK21dwTqHoeAoilEsINDZczmYs_oDhuhQRoID7hZs5zTguBj0nYgfBEtW-IkJ9N1pNtDiEtS/w400-h245/1693894979100.jpeg" width="400" /></a></div><br /><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span><p></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">eDocumentation System: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">In a digital age, documentation is crucial. Our eDocumentation system enhances transparency, traceability, and accessibility of critical trial documents. This digital repository simplifies regulatory compliance and expedites audit readiness.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Project Management Software: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Effective project management is the cornerstone of timely and successful clinical trials. We employ advanced project management software to orchestrate complex trials, ensuring that timelines are met, resources are optimized, and goals are achieved.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Central Randomization Software: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Randomization is pivotal in ensuring unbiased treatment allocation. Our central randomization software automates this process, reducing the potential for human error and enhancing the reliability of trial outcomes.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Technologically Strong and Transparent:</span></b><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Our commitment to these "tools of success" makes us technologically strong and our services transparent to our clients. The fusion of cutting-edge technology with robust Standard Operating Procedures (SOPs) ensures that our clients receive the highest quality of service, with real-time visibility into the progress of their trials.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">ICH E9 Complaint Analysis & Reporting: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">We adhere rigorously to ICH E9 guidelines for the design, conduct, analysis, and reporting of clinical trials. This ensures the highest level of scientific integrity and regulatory compliance in our studies, providing clients with confidence in the validity of our findings.</span><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Centralised Monitoring: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Our centralized monitoring approach leverages advanced technology to oversee multiple aspects of clinical trials from a central location. This proactive method allows us to detect and address issues in real-time, enhancing data quality and study efficiency.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Multi National Presence: </span></b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">With a presence spanning multiple nations, including India, Europe, the USA, and the UK, Genelife Clinical Research brings an international perspective to every project. Our diverse global footprint allows us to navigate regional intricacies and engage with a broad spectrum of patients and healthcare ecosystems.</span><span style="font-size: 10.5pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> </span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Partnering for Success:</span></b><b><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></b></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">At Genelife Clinical Research, we don't just offer services; we build collaborative partnerships. We become an extension of your team, sharing your commitment to innovation, precision, and patient well-being. Together, we navigate the complex landscape of drug discovery and development, overcoming challenges, and celebrating successes.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Join us on a journey where innovation meets efficiency, and where every trial is a step closer to transformative healthcare solutions. With Genelife Clinical Research, your path to success in clinical research is paved with technological excellence and unwavering transparency.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p align="justify" class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Contact us today, and let's embark on a partnership that redefines the future of healthcare.</span><span style="color: #374151; font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-35849671934967690382023-09-14T02:06:00.003-07:002023-09-14T02:12:52.963-07:00BA/BE Services<p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">Genelife Clinical Research is a comprehensive clinical research organization (CRO) that specializes patient based Phase I-IV clinical trials. We also provide customised services for Bio-avalabilty & Bio-equivalance studies (BA/BE studies) and Non-clinical studies. We are specialised in providing site selection, site management, and project management services for bioavailability and equivalence studies, as well as pre-clinical studies. Apart Patient based Phase I-IV clinical trials. Our commitment is to facilitate the successful execution of these pivotal phases of pharmaceutical research, adhering to the highest standards of quality, compliance, and efficiency.<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-yqdGF7996OQeud8r5pZUhxHo6sAHKaxCjvq4lySmSq3gVHnNjDVqZMQ0rVX6eWG3fFjGktXtSEOl3QvVxjvOK2y4HCJkPoaRmSVzc6Kr3G0UAC-pvs_ChCWc1JqcP0v5gT-MrAZBe7UY3fcWNNzdphYjaCf2HrCdpZ8_LAnume92TkiqMsHasb1PNivl/s743/Screenshot%202023-09-14%20at%202.22.45%20PM.png" style="margin-left: auto; margin-right: auto;"><img border="0" data-original-height="420" data-original-width="743" height="181" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-yqdGF7996OQeud8r5pZUhxHo6sAHKaxCjvq4lySmSq3gVHnNjDVqZMQ0rVX6eWG3fFjGktXtSEOl3QvVxjvOK2y4HCJkPoaRmSVzc6Kr3G0UAC-pvs_ChCWc1JqcP0v5gT-MrAZBe7UY3fcWNNzdphYjaCf2HrCdpZ8_LAnume92TkiqMsHasb1PNivl/w320-h181/Screenshot%202023-09-14%20at%202.22.45%20PM.png" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"></td></tr></tbody></table></span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"></p><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Site Selection Services:<br /></span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span><p></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Expertise Assessment:</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"> Genelife Clinical Research assesses potential research sites based on their expertise, track record, and infrastructure. We select sites that align with the specific needs and goals of your study.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Regulatory Compliance</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We ensure that selected sites adhere to all relevant regulatory guidelines, including Good Clinical Practice (GCP) standards, ethical considerations, and local regulatory requirements.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Logistics and Resources</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We carefully evaluate the availability of facilities, equipment, and resources required for sample collection, analysis, and data management, ensuring seamless study operations.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Site Management Services:</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Quality Assurance</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: Genelife Clinical Research establishes a robust quality assurance and quality control system to monitor site performance, data accuracy, and protocol compliance throughout the study.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Training and Certification</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We provide comprehensive training and certification for site personnel to ensure they fully understand and adhere to standardized procedures and protocols.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Data Collection and Management</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We implement state-of-the-art data collection and management systems, including electronic data capture (EDC) solutions, to maintain data accuracy and integrity.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Adverse Event Reporting</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: Genelife Clinical Research develops and enforces clear protocols for the reporting and management of adverse events and safety concerns, prioritizing participant safety.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Project Management Services:</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Comprehensive Project Planning</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We create detailed project plans that encompass timelines, milestones, budgets, and resource allocation for every phase of study, from site selection to data analysis. </span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Risk Mitigation</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: Genelife Clinical Research identifies potential risks and proactively develops mitigation strategies to address any issues that may arise during the course of your research.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Effective Communication</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: Our team maintains open and transparent communication channels among all stakeholders, including sponsors, regulatory authorities, research sites, and contract research organizations (CROs).</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Budget and Timeline Management</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We meticulously manage project budgets and timelines, ensuring efficient resource allocation and adherence to project milestones.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Documentation and Reporting</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: Genelife Clinical Research ensures that all documentation, including study protocols, informed consent forms, and regulatory submissions, is meticulously prepared, accurate, and submitted in a timely manner.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><b><span class="15" style="font-family: "Helvetica Neue"; letter-spacing: 0pt;">Quality Control</span></b><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">: We enforce continuous quality control measures to guarantee that your study is conducted in strict compliance with relevant regulations and standards.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="p" style="font-family: "Times New Roman"; font-size: 12pt; margin: 5pt 0pt; text-indent: 0pt;"><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;">With Genelife Clinical Research, you can trust in our expertise, dedication, and commitment to excellence as we partner with you to ensure the successful execution of your bioavailability and equivalence studies, as well as pre-clinical studies. Our services are designed to accelerate the development of safe and effective pharmaceutical products while maintaining the highest standards of quality and compliance.</span><span style="font-family: "Helvetica Neue"; font-size: 12pt; letter-spacing: 0pt;"><o:p></o:p></span></p><p class="MsoNormal" style="font-family: Calibri; font-size: 10.5pt; margin: 0pt 0pt 0.0001pt; text-align: justify;"><span style="font-size: 10.5pt;"> </span></p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-65996478390226885402023-09-07T11:20:00.003-07:002023-09-07T11:33:09.313-07:00Genelife Clinical Research Ventures into Ulcerative Colitis Research!<p> <span style="caret-color: rgb(0, 0, 0);">We are elated to share a momentous achievement at Genelife Clinical Research Pvt. Ltd. – the recent acquisition of an Ulcerative Colitis study. This marks a pivotal moment in our journey as we delve into this therapeutic window, advancing our commitment to innovative and impactful clinical research.</span></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">A Glimpse into Our Journey:</p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">With a history spanning over 13 years and 55+ clinical studies, our venture into this Ulcerative Colitis study is particularly significant. It represents only our second foray into this therapeutic domain, building upon the foundation laid by a prior 505(b)(2) study conducted some time ago.<br /></p><div class="separator" style="clear: both; text-align: center;"><br /><br /></div><p></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">Why This Matters:<span class="Apple-converted-space"> </span></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">The addition of this Ulcerative Colitis study to our portfolio underscores our dedication to expanding our expertise and contributing to healthcare advancements. Ulcerative Colitis is a challenging condition with a global impact, and we are resolute in our commitment to be part of the solution.</p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">Our Approach:<span class="Apple-converted-space"> </span></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">At Genelife Clinical Research, our approach is defined by meticulous planning, unwavering scientific rigor, and an unwavering commitment to the highest standards of quality and compliance. We harness our extensive experience and innovative methodologies to drive progress in this study.</p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">What Lies Ahead:<span class="Apple-converted-space"> </span></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">As we embark on this exhilarating journey, we eagerly anticipate collaborations with hospitals and doctors who share our vision of effecting positive change in Ulcerative Colitis research. Together, we aspire to unveil valuable insights, pioneer new treatments, and enhance the lives of those grappling with this challenging condition.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgf4rU9ll7_ONVH9RSBrOtMsrsihuiGeyGxQjAySjxxCWCXaZi5T8TDyme9OZnSaMZcMIhIj5M4nYN1J0ujJxybNcR4w8mEkNF6Ay_UmipkBP_KIAB0MUK_dtLVNuChZ4uGoQUVb6rdlx6s7BGRM5XgcGon2SMpD8dQ1qLOdYxUmv9uBz5ehcY01ymVr_gI/s646/Design.jpeg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="256" data-original-width="646" height="127" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgf4rU9ll7_ONVH9RSBrOtMsrsihuiGeyGxQjAySjxxCWCXaZi5T8TDyme9OZnSaMZcMIhIj5M4nYN1J0ujJxybNcR4w8mEkNF6Ay_UmipkBP_KIAB0MUK_dtLVNuChZ4uGoQUVb6rdlx6s7BGRM5XgcGon2SMpD8dQ1qLOdYxUmv9uBz5ehcY01ymVr_gI/s320/Design.jpeg" width="320" /></a></div><p></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">Stay Tuned:<span class="Apple-converted-space"> </span></p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">We invite you to stay tuned for updates on our Ulcerative Colitis study and the progress we make along the way. At Genelife Clinical Research, we are committed to excellence, innovation, and the pursuit of meaningful solutions in the world of clinical research.</p><p class="article-editor-content__paragraph" style="caret-color: rgb(0, 0, 0);">Thank you for joining us on this exciting path towards scientific discovery and improved patient outcomes. Together, we can make a difference.</p>Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-3848386746637741972019-07-12T03:32:00.000-07:002019-07-12T23:33:30.737-07:00Drug Resistant Tuberculosis<div dir="ltr" style="text-align: left;" trbidi="on">
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<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";">Tuberculosis (TB) is a
disease widespread throughout the world caused by Mycobacterium tuberculosis.
Despite the strict developed strategies for TB control and significant increase
in knowledge of the epidemiology of tuberculosis as well as mechanisms for
survival of causative agent of tuberculosis, the disease remains one of the
most common and deadly.<o:p></o:p></span></div>
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGUCDo-7VsKn0EPfTf6Vgx8TRPXXpT_owZF4T-ZCPKUY3S1psm3rkLNTwtybHorYE26qd__xwxfQiv_3pVfcbgyDZlpCnYu-fOyjbjh2gv4IXWTJao43xin4RLHMrcP3LRl2Iw1oDauypw/s1600/Screen-Shot-2017-09-04-at-10.24.13.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="854" data-original-width="1018" height="268" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGUCDo-7VsKn0EPfTf6Vgx8TRPXXpT_owZF4T-ZCPKUY3S1psm3rkLNTwtybHorYE26qd__xwxfQiv_3pVfcbgyDZlpCnYu-fOyjbjh2gv4IXWTJao43xin4RLHMrcP3LRl2Iw1oDauypw/s320/Screen-Shot-2017-09-04-at-10.24.13.png" width="320" /></a></div>
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<span style="font-family: "times new roman" , "serif";"><br /></span></div>
<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";">Due to developing genetic
mutations in any quite large population of Mycobacteria tuberculosis, there are
naturally formed mutant strains with drug resistance. At the same time due to
development of resistance to one drug, there is greater tendency of
mycobacteria to further acquiring resistance to other drugs, which leads to
emergence of strains resistant to multiple drugs simultaneously. Patients with
multidrug-resistant tuberculosis can be sources for the spread of resistant
strains of mycobacteria, which leads to identification of "primary"
drug resistance in patients with newly diagnosed tuberculosis.<o:p></o:p></span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;"><br /></span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">Multi Drug-Resistant (MDR) TB is treatable and curable by using
second-line drugs. However, second-line treatment options are limited and
require extensive chemotherapy (up to 2 years of treatment) with medicines that
are expensive and toxic.</span><span style="font-size: 11.0pt; line-height: 115%;"><o:p></o:p></span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;"><br /></span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">In some cases, more severe drug resistance can develop.
Extensively Drug-Resistant TB (XDR-TB) is a more serious form of MDR-TB caused
by bacteria that do not respond to the most effective second-line anti-TB
drugs, often leaving patients without any further treatment options.</span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;"><br /></span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">Additionally, people living with HIV are 20 to 30 times more
likely to develop active TB disease than people without HIV.HIV and TB form a
lethal combination, each speeding the other's progress. In 2016 about 0.4
million people died of HIV-associated TB. About 40% of deaths among
HIV-positive people were due to TB in 2016. In 2016, there were an estimated
1.4 million new cases of TB among people who were HIV-positive.</span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<br /></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<span style="border: none windowtext 1.0pt; font-size: 11.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">In 2016, MDR-TB remains a public health crisis and a health
security threat. WHO estimates that there were 600 000 new cases with
resistance to rifampicin – the most effective first-line drug – of which 490
000 had MDR-TB. The MDR-TB burden largely falls on 3 countries – India, China
and the Russian Federation – which together account for nearly half of the
global cases.</span></div>
<div style="background: white; line-height: 115%; margin-bottom: .0001pt; margin: 0in; text-align: justify; vertical-align: baseline;">
<br /></div>
<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";">India has highest burden of both
TB and MDR-TB based on estimates reported in Global TB Report 2016. An estimated
1.3 lakh incident multi-drug resistant TB patients emerge annually in India
which includes 79000 MDR-TB Patients estimates among notified pulmonary cases.
India bears second highest number of estimated HIV associated TB in the world.
An estimated 1.1 lakh HIV associated TB occurred in 2015 and 37,000 estimated
number of patients died among them.</span></div>
<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";"><br /></span></div>
<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";">Control and treatment of MDR-TB
became one of the priorities due to awareness of the problem, increase of
material and technical facilities as well as distribution of evidence-based
medicine. Intensive introduction of alternative and additional treatment
strategies is required in order to take control of the serious problem of
MDR-TB.</span></div>
<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";"><br /></span></div>
<div class="MsoNormal" style="line-height: 115%; text-align: justify;">
<span style="font-family: "times new roman" , "serif";">The pipelines for new
diagnostics, drugs, treatment regimens and vaccines are progressing, but
slowly. Increased investment in research and development is needed.</span><br />
<span style="font-family: "times new roman" , "serif";"><br /></span>
<span style="font-family: "times new roman" , "serif";">The treatment of drug resistant TB has always been more difficult than the treatment of drug susceptible
TB. It requires the use of second line or reserve drugs that are more costly and cause more side effects.
Also the drugs must be taken for up to two years. Fluoroquinolones (FQs) are effective against Mycobacterium tuberculosis and are used in the treatment of
multidrug-resistant tuberculosis (MDR-TB). As measured by the in vitro activity against Mycobacterium
tuberculosis, the most potent of the currently available fluoroquinolones are, in descending order,
moxifloxacin, gatifloxacin, levofloxacin, ofloxacin, and ciprofloxacin. M. tuberculosis clinical isolates
that demonstrate high-level phenotypic resistance to fluoroquinolones, which appears to be predominantly
due to gyrA mutations, exhibit cross-resistance to all six important fluoroquinolones. Patients with prior
exposure to any of the quinolones are likely to develop resistance to other quinolones. Quinolones being
broad spectrum antibacterial agents, their widespread and indiscriminate use, often in subtherapeutic
doses, is likely to rapidly enhance quinolone-resistant organisms, including mycobacteria.
There is rampant use of FQ drugs for undiagnosed respiratory infections in India, which has contributed
to the emergence of FQ resistance in M. tuberculosis, which may in turn influence the clinical outcome of
MDR-TB patients. For a long time now there has been no new established drug available for MDR TB.
At present we are left with few bacteriostatic antitubercular drugs. Reports of quinolone-resistant
tuberculosis are constantly pouring in </span><span style="font-family: "times new roman" , serif;">and should act as a warning sign for the bleak future of cases of
MDR-TB, because we are rapidly losing a very effective group of drugs for the management of such
cases.
Moreover, it is recommended that ofloxacin is phased out from MDR-TB regimens and ciprofloxacin is
never used due to the limited evidence for its effectiveness.</span><br />
<span style="font-family: "times new roman" , serif;"><br /></span>
<span style="font-family: "times new roman" , serif;">#mdrtb #tuberculosis #antituberculosis #drugs #hiv #tb #treatment</span></div>
</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com2tag:blogger.com,1999:blog-2937117122788051753.post-41804821492707228492016-02-22T11:02:00.002-08:002016-02-22T11:02:48.529-08:006th Anniversory <div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjvVBnMlw9z7UfZmHk6aQ90oHS0m37JmVC8bYcgV62ITtqvJqeCDr2XSlbkwOGhLlQSvYEIoLFNI-RuQ6PTxQWcNr3t208DMjhNoLOgND-SkZcEsuRcuxIV4MlTGfF6P_gJHdcGNI63CxFp/s1600/Capture.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="403" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjvVBnMlw9z7UfZmHk6aQ90oHS0m37JmVC8bYcgV62ITtqvJqeCDr2XSlbkwOGhLlQSvYEIoLFNI-RuQ6PTxQWcNr3t208DMjhNoLOgND-SkZcEsuRcuxIV4MlTGfF6P_gJHdcGNI63CxFp/s640/Capture.PNG" width="640" /></a></div>
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Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com3tag:blogger.com,1999:blog-2937117122788051753.post-66516981580607231762015-10-18T05:42:00.000-07:002015-10-19T06:52:19.849-07:00History of Clinical Research Regulation in India <div dir="ltr" style="text-align: left;" trbidi="on">
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All regulatory bodies has the responsibility to
provide access to the safe, effective and quality, medication to their
people.<span style="mso-spacerun: yes;"> </span>The Central Drugs Standard
Control Organization and Drug Controller General of India are bequeathed to
protect the citizens from the exposer of unsafe medication. Either it is
through clinical research or marketing. The growing clinical research after the
product patents rights for the pharmaceutical industries as per the trade
related aspects of intellectual property rights agreement and adverse drug
reaction monitoring, rights and safety of Patients, compensation after adverse
event clinical research and of the marketed drugs have raised many ethical and
regulatory issues. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
The regulatory measures has to be dynamic and ever
evolving in consonance with the developing technologies. Indian regulations have also experienced this a lot of change from british era. Last three years were little disturbing and this lead to loss of opportunity and mistrust in Pharmaceutical domain. But now regulation is well organized, systematic and compliant
to international regulatory standards for pharma products, medical devices,
traditional herbal products and cosmetics. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
Now question arise why Indian regulators took so
much time in this reform? To understand this we have to understand the history
of Clinical research. It started in British Raj when most of the drugs were
imported from foreign countries. Post First World War, the demand for drugs had
increased tremendously and that led to the cheap, substandard, spurious and
adulterated drugs into the market. To control in market, Government passed the
Poisons Act 1919. This Act regulates possession of substance or sale of
substances as specified as poison. The Poisons Act was followed by The
Dangerous Drugs Act 1930. This act regulates the opium plant cultivation,
manufacture and possession of opium, its import, export, tranship and sell of
opium.</div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
In response to widespread ‘Gigantic Quinine Fraud’;
the Government, then, formed a Drug inquiry committee under Sir Ram Nath Chopra
also known as ‘Chopra Committee’ whose recommendations later on tabled amidst
growing protest in legislative assembly as ‘The Drug Bill’ later on amended to
the Drugs and Cosmetic Act 1940 (D and C Act) and Drugs and Cosmetic rules of
1945. This also established the Central Drugs Standard Control Organization
(CDSCO), and the office of its controller, the Drugs Controller General (India)
(DCG(I)).<span style="mso-spacerun: yes;"> </span>The CDSCO in the Directorate
General of Health services, is a division in Ministry of Health and Family
welfare, Government of India, headed by Drug Controller General of India (DCGI).
It has four zonal, three sub-zonal and seven port/airport offices and six
laboratories to carry out its activities. The Drugs and Cosmetic Act, 1940 came
into force from 1st April 1947. In year 1948 Pharmacy Act came into existence
to regulate the profession of pharmacy in India and in 1955 Drugs and Magic
Remedies rule came into existence for control the claim and advertisement. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
In 1962, government extended the regulatory
provisions to the cosmetics, and finally the Act came to known as Drugs and Cosmetic
Act 1940. Drugs and Cosmetic Act has been divided in Chapters, Rules and
Schedules and is amended from time to time to control the safety, efficacy and
quality of the drugs. It is an act to regulate the import, manufacture,
distribution and sale of the drugs and cosmetics. Manufacture and sale is under
the respective states governments and union territories through their
respective drug control organization, whereas setting standard, import,
marketing authorization and monitoring of adverse drug reactions of a new drug
is under Central Government. Under Chapter Two of this Act, one statutory board
and a committee have been framed called Drugs Technical Advisory Board (DTAB)
and Drug Consultative Committee (DCC) separately for Modern Scientific System
of Medicine and Indian traditional system of Medicine and a provision of
Central Drug Laboratory at Central Research Institute, Kasauli for testing
drugs has been made in this act. DTAB comprises of technical experts who
advises central and state governments on technical matters of Drug regulation.
Amendment, if any, to Drug and Cosmetic are made after consulting this board. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
During this period the market share was dominated
by multinational companies and very few Indian manufacturers were present. The
Indian Pharmaceutical industry was in an early stage of growth. Focus for pure
research and development was very little due to lack of patent protection. Due
to very high import dependency on drugs, the cost of drugs was very high as
well as market availability was comparatively low. In 1955, government has
passed Drugs Prices Control Order, 1955 (DPCO) (under the essential commodities
Act). Due to which many essentials drugs were unavailable in Indian market. To
save Indian companies and to provide medicine Indian population at low cost Indian
government introduced Indian Patent Act of 1970. This new act replaced the
Indian Patents and Designs Act of 1911. <span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
The Indian Patents Act of 1970 originally had
provisions for ‘process’ patents only. Now, local companies began manufacturing
products/ drugs using different manufacturing process by reverse engineering.
Due to this new drugs were available cheaply as well as many more substitute
drugs were available in the market against costly imported new drugs. This has
resulted in 1) increase the exports to countries like Russia, Africa, China,
and South America. 2) Export of Bulk drug post patent expiry.</div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
In 1994, Government signed the agreement on Trade
Related Aspects of Intellectual Properties (TRIPS) to provide minimum
protection to the Intellectual Property by the member states of World Trade
Organization (WTO). India amended the Patent (Amendment) Bill before 2005 and
extended its weak process patent to strong TRIPS competent ‘Product’ patent
system for pharmaceutical products. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
The Indian government, realizing the potential of
clinical research for new therapies, has modified and amended Schedule Y to the
Drug and Cosmetics Rules of 1945. Schedule Y establishes a set of guidelines
and requirements for clinical trials. However, Schedule Y was written with the
generics industry in mind but increase entry of foreign pharmaceutical
companies after the introduction of strict patent rules in the area of clinical
research led the government to introduce many changes. The government
recognized the importance of their regulation and thus developed Ethical and
Regulatory Guidelines. The Indian Council of Medical Research (ICMR) issued the
Ethical Guidelines for Biomedical Research on Human Subjects in 2000 and CDSCO
released Indian Good Clinical Practice (GCP) guidelines in 2001. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
With the application of Product patent in 2005,
recognizing individual's innovations through the Trade Related Aspects of
Intellectual Property Rights (TRIPS) agreement, which India had signed in 1995,
became effective. Indian companies began to respect Intellectual Property
rights, consistent with international standards. With the increasing faith in
the system, companies flooded the market and more global trials came. Lately,
to decrease the review time of application from 16 weeks to 10 weeks the CDSCO
has introduced the fast tracking of clinical trials in 2006. The DCG (I)
created two categories of applications; Category: (A) Those also being
conducted in countries with competent, mature regulatory systems, and Category:
(B) Everything else.</div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
Trials that fell into category A (received approval
in the U.S., Britain, Canada, Germany, South Africa, Switzerland, Australia,
Japan and countries in the European Medicines Agency (EMEA)) would be eligible
for fast tracking in India, with approval taking no more than two to four
weeks. Trials in category B would fall under more scrutiny; with approval
taking 12 weeks once an application is considered under Category B, it, in any
case, cannot be shifted to Category A. Nearly all global trials are in the
Category A. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
In 2011, Drugs and Cosmetics (First Amendment)
Rules was implemented. It mandates registration of Clinical Research Organization
(CRO) for conducting Clinical Trials (CT). Schedule Y suggests requirements and
guidelines for registration of Clinical Research Organizations. Although
amendment to Schedule Y, registration of Contract Research Organizations,
registration of Clinical Trials, Speeding up review process, Pharmacovigilance
(PV) programme for India and Inspection of clinical trial sites have been
started. However due to casual approach in marketing approval, unethical steps
taken by some pharmaceutical companies and medical practitioners has reiterated
the need to amend the regulations. DCGI slowed down their actives related to
approval of studies as per the guidance of Supreme Court and Government of
India and started concentrating on the regulatory framework. </div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
DCGI further amended the policies for to improve
the quality of clinical research. It took three years to design this:</div>
<ul style="text-align: justify;">
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>Sponsors, investigators, the regulator and
Ethics Committees are responsible for ensuring that the design of
placebo-controlled trials is appropriate, efficient and ethical; </li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>The Ethics Committees will have to be registered
under DCGI</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>Investigators are limited to working on a
maximum of three trials simultaneously; </li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>If a new chemical entity is approved in the
innovator or “well-regulated” country for a disease prevalent in India, and the
clinical trial included Indian participants, CDSCO advises that “approval
should be sought from CDSCO” and “these NCEs should be marketed in India
speedily.” CDSCO also specifies that if a foreign trial included Indian
participants, the number would have to be “adequate” for considering approval
of the drug in India;</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>Waiver of clinical trials in Indian populations
with drugs already approved outside India will only be considered in cases of
national emergency, extreme urgency and epidemic, and for orphan drugs for rare
diseases and drugs for conditions/diseases for which there is no therapy;</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>Generics and biosimilars marketing “in other
countries like USA” for over four years and have a “satisfactory report” can be
approved in India after abbreviated trials;</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>Consideration of new drug applications will take
into account ethnic differences in metabolism etc.;</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>If two or more countries remove a drug from
their market on the grounds of safety and efficacy, the continued marketing of
the drug in India “will be considered for examination and appropriate action”
by CDSCO; and</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>Manufacturers, sponsors and CROs are advised to
provide compensation for any drug-related anomaly detected at a later stage.</li>
<li><span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span>CDSCO is also re-organizing the structure of the
committees involved in the drug approval process. The New Drug Advisory
Committees will now become the Subject Expert Committees, whose recommendations
will be reviewed by a newly formed Technical Review Committee (TRC). The
TRC will be under the direction of the Directorate General of Health Services
(DGHS), which will draw the membership of the committee from experts in such
areas as clinical pharmacology, clinical toxicology/ pathology, and scientists
involved in drug development. </li>
</ul>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<div>
<span style="mso-spacerun: yes;"></span>As we all understand that regulatory improvement is
continual process and no system is perfect. DCGI still needs a lot of
improvement to ensure safety and wellbeing of Indian population along with
promoting introducing new product.</div>
<div class="separator" style="clear: both;">
</div>
<br />
<div class="separator" style="clear: both;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjuCT2jkLqUMKMmnq5J5J9sDT4i4efiqK_uk3yiz5ermfigR0ttcojyznxeNYMu_i4EbsAxTTd483qvoRqD_2Bqqz7_aNIKMxbJvAutFdxoKg4_PoQPtiBoOWO_lolikBmHYeppZ7jSA0oj/s1600/Genelife1.png" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="105" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjuCT2jkLqUMKMmnq5J5J9sDT4i4efiqK_uk3yiz5ermfigR0ttcojyznxeNYMu_i4EbsAxTTd483qvoRqD_2Bqqz7_aNIKMxbJvAutFdxoKg4_PoQPtiBoOWO_lolikBmHYeppZ7jSA0oj/s200/Genelife1.png" width="200" /></a></div>
</div>
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Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com4tag:blogger.com,1999:blog-2937117122788051753.post-69105730063655072812015-07-20T01:22:00.001-07:002023-08-14T05:23:53.464-07:00Medical device clinical trials<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="comment-header" id="bc_0_0M" kind="m" style="text-align: justify;"><br /></div>
<div style="text-align: center;">
<br /></div>
<div class="comment-content" id="bc_0_0MC" style="text-align: justify;">
Unlike
Pharmaceutical technologies, there are no dedicated established centers-
MEDICAL DEVICE CROs in ample amount which could satisfactorily
facilitate a medical device product evaluation and commercialization nor
clinical evaluation guidelines in medical devices sector i.e.
ISO-14155, ICH-GCP in adaptation oriented towards medical devices are
taught in institutions so as to enable the students take such projects
and come up with an excellent guideline document for producing local,
national or global impact.<br /><br />Medical device related health
economics: The education could be imparted with Intended Learning
Objective (ILO) of providing insight to economic evaluation of clinical
effectiveness or diagnostic accuracy of medical devices with respective
cost dimensions. This may comprise projects like preparation of costs
database, estimation of budget for reimbursement schemes on medical
device failure and so on.<br /><br />Medical Technology Surveillance: There
is little guidance available in field of post-marketing surveillance of
medical devices especially in India. Unlike PvPI and hemovigilance, no
such programme is available for medical devices. A model or strategy for
the same could be invoked for purpose of brainstorming in students.<br /><br />Regulatory
Affairs and Standardization: Understanding how to put boundaries to
innovations while their diffusion is something highly expected to be
taught. It is fact that MATLAB,LABVIEW related digital image processing
projects are promoted always but no project is seen which might have
explored ethical issues related pros and cons associated with image
processing i.e. violation of PNDT act, misdiagnosis of any abnormality
or disorder. Moreover, there is less education provided on CE marking,
Medical device standards, Medical device testing.<br /><br />Intellectual
Property Rights: No course I came across so far incorporates this aspect
from project perspective i.e. project on assessing IPR issues faced by
device manufacturers, comparison of device patentization framework of
different countries, petty patents.<br /><br />Bridging translational gap:
It is hard fact that even after outstanding project model, there is no
support in terms of how to accelerate it for professional growth with
commercialisation purposes. Most of projects are just for sake of
completion and not with realization and/or continuation of further
journey. Such lacking in system is also proposes threat of plagiarised
projects (ready-made models/circuits in markets) or “frog-in-well”
approach during project.<br /><br />I believe if this type of thinking could
be done "apriori", then biomedical engineering’s value could be
realised like never before. And also I believe that these aspects, when
ingrained in curriculums, it would be “pride” rather than
“speechlessness” or “cluelessness” when somebody would ask the reason
for choosing this branch.<br /><br />I would be happy to see as many as comments and suggestions for this post.<br /><br />Let's start our journey for evidence-based-medical device research and development !!</div>
</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-76107173302037779562015-02-26T05:53:00.002-08:002019-07-12T03:39:08.394-07:00Genelife Clinical Research: 5th Anniversary<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<br />
<div style="text-align: justify;">
<span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="font-size: small;">As Genelife Clinical Research is growing 5 year
old on February 26, 2015, with the steadfast confidence of Clients, Consultants
and employees have shown to Genelife Clinical Research by entrusting to her
services. When our company was founded in 2010 with a very small team, we could
hardly foresee our growth to an international company with a staff of 32 within
this short span of time. Many people predicted we will not last a year in the
industry because we were too idealistic and simple to cope with business
environment. Fortunately, we survived not only the initial phase but also the
most difficult phase of Indian Clinical Research industry. When I started this
organization I had a clear vision for success. I wished to create an amazing
environment and hire the smartest people. Together we will build a beautiful
system to delight the customers and makes the world just a little bit better. I
started working night and day to make my vision “to be most respected CRO” reality,
but the things did not go as planned due to some external and financial issues.
Fortunately, we came out of that with some unexpected luck and trust of our
clients. Every member of Genelife team have worked hard to make sure Genelife’s
success and celebrate 5th anniversary.</span></span><br />
<div class="separator" style="clear: both; text-align: center;">
<span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="font-size: small;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEif56rKxguJU2oRbZZGpSIrxkxehfapDGvkWpypIFxz_A_I2mOuR5bShbuW1HkI99dV8BjqsSiOHWO4HWnz-LdORL5hhN_o3FNji4Oos9g4aQ4nYe9ztAj6XEUqUOtpQldMufSN1UKUftia/s1600/IMG-20150226-WA0040+(2).jpg" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="181" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEif56rKxguJU2oRbZZGpSIrxkxehfapDGvkWpypIFxz_A_I2mOuR5bShbuW1HkI99dV8BjqsSiOHWO4HWnz-LdORL5hhN_o3FNji4Oos9g4aQ4nYe9ztAj6XEUqUOtpQldMufSN1UKUftia/s1600/IMG-20150226-WA0040+(2).jpg" width="320" /></a></span></span></div>
<br />
<br />
<span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="font-size: small;">Five
year
is long time as well as short time, compared to a big companies like
Quintiles, we are still adolescent. On the other hand, five years in a
sector
that is constantly and rapidly advancing is an achievement, we can be
proud of.
It means we have managed to establish ourselves in this sector. We have
claimed
our rightful place here. This reflects with the kind of work we are
doing. Currently we are having maximum approved studies in India with
one of the best operations tools to run these projects. Deliverability
has been our strength for retaining all business we have.</span></span><br />
<br />
<span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="font-size: small;">Since inception Genelife Clinical Research capitalized on the
company's vision “to become the most respected CRO”. In these 5 years we have
translated our knowledge into a full portfolio of drug development which
empowers clients to close the gap between their requirement and regulatory
needs. In near future, we aim to expand our horizons into the field of BA/BE,
Pharmacovigilance as well as studies conducted in other Regulated market in and
outside India. Keeping past experiences as well as future dreams in our mind,
Genelife Clinical Research shall strive hard to reach the highest peaks with positivity, quality
and excellence and make a noteworthy contribution in the field of Clinical
Research. </span></span></div>
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Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-91703295185820031372014-09-10T00:04:00.003-07:002023-08-14T05:24:54.379-07:00Genelife Chem<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgMBlR_dF58KQZtOvFobewbmgmz4XoaDJYZvXo2aOgpPuOck8k_cIUpNpsniDfWyxJnVae7HU0j7VEn2iu20RSFULffK0ofYwJWVce8yxUX5fmJaB8C8N7jtXqR8zvtMnoG_VGLDMXMY_lL/s1600/1920608_732058916841597_2621539759415934375_n.jpg" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="112" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgMBlR_dF58KQZtOvFobewbmgmz4XoaDJYZvXo2aOgpPuOck8k_cIUpNpsniDfWyxJnVae7HU0j7VEn2iu20RSFULffK0ofYwJWVce8yxUX5fmJaB8C8N7jtXqR8zvtMnoG_VGLDMXMY_lL/s1600/1920608_732058916841597_2621539759415934375_n.jpg" width="200" /></a><span class="userContent" data-ft="{"tn":"K"}">Genelife
Clinical Research is starting its division Genelife Chem. Genelife Chem
will be a collaborative drug discovery partner based out in, Pune, India. Like
Genelife Clinical Research the Vision of this Genelife Chem will be “To
be the most respected partner". We are setting up this new venture with
state of art infrastructure and one of best talent in Asian
subcontinent to partner with innovators in <span class="text_exposed_show">their early drug discovery and development programs etc. We have experiences Chemists to devise the synthetic strategy and deliver the desired molecule with excellent purity and structural integrity. </span></span> <!--[if gte mso 9]><xml>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4x7THiY-70sDxNDhKJNlBsn1fqmiRvlM-NCUyIIBRdRVpUa4K0k96JEqiSZbIO0cc5NdOWIt5Mo4DsHQecimCs7TSZYXhdh2BTYHQ4DTkAo6udVRClUmRsUIR3MNpIYg1pDEhyDmrRLl9/s1600/997052_732058866841602_2057923938438194362_n.jpg" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="112" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4x7THiY-70sDxNDhKJNlBsn1fqmiRvlM-NCUyIIBRdRVpUa4K0k96JEqiSZbIO0cc5NdOWIt5Mo4DsHQecimCs7TSZYXhdh2BTYHQ4DTkAo6udVRClUmRsUIR3MNpIYg1pDEhyDmrRLl9/s1600/997052_732058866841602_2057923938438194362_n.jpg" width="200" /></a><span face=""Verdana","sans-serif"" style="color: black; font-size: 10pt; mso-ansi-language: EN-US; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;"></span><br /><span class="userContent" data-ft="{"tn":"K"}"><span class="text_exposed_show"></span></span><span class="userContent" data-ft="{"tn":"K"}"><span class="text_exposed_show"> <br />
With this note, we would like to introduce you with the services we are
offering in drug discovery & development space under flexible
business models. At present our main focus is chemistry that is the
backbone of most of the life science programs.<br /> <br /> Services:
Structure-based design; Fragment optimization; hit to lead; Synthetic
organic chemistry; Library design and multiple parallel synthesis;
Synthesis of reference compounds; Non-GMP and GMP scale-up synthesis;
Route scouting; optimization of reaction conditions and critical process
parameters.</span></span></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBppHr_mGBPnfqivaaqmG5D8wgScaQEE-vMoE8Z6iThRlBjDuON75BWV_Habj4_0jOSB-ZaA6Pvo3a7JWTL0I6jyZMsug6RdXju4QKMNxWNUuf3UYVf4yIngSfn5Pb5K_6kb1G5khqfFbB/s1600/10502513_732058823508273_6743415017546141085_n.jpg" style="margin-left: 1em; margin-right: 1em;"></a><div class="separator" style="clear: both; text-align: justify;">
In 1st week of inception only, Genelife
Chem has entered into a joint drug discovery collaboration with one of
the biotechnolgy company based in USA to develop kinase inhibitors.
Genelife chem will be responsible to provide synthetic and medicinal
chemistry expertise while the collaborator holds the responsibility of
biological screening of new chemical entities against a kinase panel.</div>
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Genelife Chem is looking forward to serve the client in best possible way in order to earn same trust, faith and support which its parent company has achieved. </div>
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Kind regards,</div>
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Dhirendra V. Singh</div>
<span class="userContent" data-ft="{"tn":"K"}"></span></div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-47529489642256304802014-06-10T09:40:00.001-07:002016-02-09T02:27:14.998-08:00Medicinal Plants In Health Management<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">The struggle of a man against disease and death is as old
as the history itself. On the basis of skill, knowledge and practices based on
the theories, beliefs & experiences indigenous all civilizations has
developed their own treatment system which is now called as traditional
treatment system. The base of almost all such treatment system is plants. Various
as scholar and medical men, since the vedic period dawn to the present century,
have contributed a lot on the use of medicinal plants in health care.</span></div>
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<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjIfGt6dIzurQweBfGuRup_WvJS1CjWZGi_Tb1pObx33LEKHKeO-2ILKB_h5g_5-DiiBqEu5f6IOf8Oaho7-N8HSnVxA6XeJ4lSpweC_i8tpjlFyRjljzQnwD9kfjnt7inVplL-LqjAKD6j/s1600/medical-marijuana-drug-stoner-druggie-potted_plant-hbrn63l.jpg.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjIfGt6dIzurQweBfGuRup_WvJS1CjWZGi_Tb1pObx33LEKHKeO-2ILKB_h5g_5-DiiBqEu5f6IOf8Oaho7-N8HSnVxA6XeJ4lSpweC_i8tpjlFyRjljzQnwD9kfjnt7inVplL-LqjAKD6j/s1600/medical-marijuana-drug-stoner-druggie-potted_plant-hbrn63l.jpg.png" width="188" /></a><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Plants are the most ancient source of drugs and the plant
based medicaments, the countrymen’s prime therapeutic weapon, are still is
front line today for treating a large number of diseases. According to
Professor N.R. Fransworth the plants are “The sleeping giants of drug
development today and will represent in future as first class source for new
medicaments.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">The most established traditional system is Ayurveda. The
objectives of Ayurveda are Dhatu Samya, Swastha Vritta and Atura Vritta. Proper
cure of a disease entirely depends upon rational interaction of four limbs of
therapies or chikitsa chatushpada and drug is one of the components of therapy.
The material Media of Ayurveda is very vast. It comprises of Plants, animals
and metals and aquatic products but plant drugs occupy a large area for the
prevention and promotion of health and treatment of Disease.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQVPXprbt3FU1i-9mEh9RtrwIo0qkk3OhUR4bsHYnoSvHqzt2yoQ2BASi3qj9UBH0cXUqoaucywQo4KAXfdcfldE0BVYbHICpaZffJTE2mPLVDqcmK_XjPCM07zysD6Ga0_8Ub9T53VS8j/s1600/KIMP_TULSI_G7C5073_1101156e.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQVPXprbt3FU1i-9mEh9RtrwIo0qkk3OhUR4bsHYnoSvHqzt2yoQ2BASi3qj9UBH0cXUqoaucywQo4KAXfdcfldE0BVYbHICpaZffJTE2mPLVDqcmK_XjPCM07zysD6Ga0_8Ub9T53VS8j/s1600/KIMP_TULSI_G7C5073_1101156e.jpg" width="156" /></a><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">It may be noted that Ayurveda (sanskrit Ayur : life, Veda
: science, Knowledge) is the ancient Indian system of health management which
is still widely practiced in the sense of “holistic’ approach, especially for metabolic
disorders. Ayurvedic medicines are mostly based on plant materials. The entire mountainous
region of the country is considered a vast repository of medicinal herbs. It
has been estimated that the sources of 80% Ayurvedic medicines are found in the
western Himalayas.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">A medicinal plant is any plant which is one or more of
its organs substances that can be used for therapeutic purposes or which are
precursors for chemo pharmaceutical semi-synthesis. The definition makes it
possible to distinguish between the medicinal plants that are already known whose
therapeutic character or a precursor of certain molecular have been established
scientifically and the other plants which are regarded as medicinal but have
not yet been subjected to thorough scientific study. Researches for the
identification, development and utilization of plants should be given high
priority for the development of Indigenous system of health care in order to
reduce drug bills and develop more acceptable and more readily acceptable to
the people and with better coverage.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">The following are the some of the examples of plants
which are used in primary health care extensively specially in the Rural Area:</span></div>
<table border="0" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; margin-left: 4.65pt; mso-padding-alt: 0in 5.4pt 0in 5.4pt; mso-yfti-tbllook: 1184; width: 619px;">
<tbody>
<tr style="height: 15.0pt; mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">1</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Tulsi</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Ocimum sanctum</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Promotes immunity</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 1;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">2</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Bhallatak</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Semicarpus anacardium</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Anti-cancer agent</span></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 2;">
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">3</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Ashwagandha</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Wiothania somnifera</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">General nervine
tonic</span></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 3;">
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">4</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Amalaki</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Emblica officinals</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Rejuvenate (resayana)</span></div>
</td>
</tr>
<tr style="height: 45.0pt; mso-yfti-irow: 4;">
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">5</span></div>
</td>
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Manookharni</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">(Brahmi)</span></div>
</td>
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Hydsrocotyl ariatica</span></div>
</td>
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Improves memory and
intelligence</span></div>
</td>
</tr>
<tr style="height: 45.0pt; mso-yfti-irow: 5;">
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">6</span></div>
</td>
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Shankhapushpi</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Convulvulus pluricalis</span></div>
</td>
<td nowrap="" style="height: 45.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Improves memory and
intelligence</span></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 6;">
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">7</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Vacha</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Acorus colamus</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Improves speech in
children</span></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 7;">
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">8</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Jyolishmati</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Collesterus
pariniculala</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Improves mental health</span></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 8;">
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">9</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Arguna</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Terminalia Arjuna</span></div>
</td>
<td nowrap="" style="height: 30.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Most effective cardio
tonic</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 9;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">10</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Shirish</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Albebia lebeck</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Anti-asthma</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 10;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">11</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Haridra</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Curcuma longum</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Anti-Allergic</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 11;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">12</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Katuki</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Picrorrhiza Kurroa</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Jaundiced Hepatitis</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 12;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">13</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Punarnawa</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Boerhavia diffusa</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Kidney disorders</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 13;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">14</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Varuna</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Gitavia deligiosa</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Bladder disorders</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 14;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">15</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Kapikachu</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Mucona Pruriens</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Impotency</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 15;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">16</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Shatavari</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Asparagus racimosus</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Galactogogue</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 16;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">17</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Bala</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Sida cardifolia</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Baby tonic</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 17;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">18</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Japakusum</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Haviscus Rosa cyanosus</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Antifertility agent</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 18;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">19</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Vijaysar</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Ptericorpus Marsupium</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Ant diabetic</span></div>
</td>
</tr>
<tr style="height: 15.0pt; mso-yfti-irow: 19; mso-yfti-lastrow: yes;">
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 32.2pt;" valign="top" width="43"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">20</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 93.55pt;" valign="top" width="125"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Kutaj</span><span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;"></span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 154.0pt;" valign="top" width="205"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Holerene
Antidysenterica</span></div>
</td>
<td nowrap="" style="height: 15.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 184.5pt;" valign="top" width="246"><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "arial" , "sans-serif"; font-size: 12.0pt;">Colitis</span></div>
</td>
</tr>
</tbody></table>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Some of the drugs which have come to light in our
experience to have significant action and the observation have been also
supported. Scientific observations are as follows</span><br />
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;"><b>Psychotropic drugs</b> : A group of drugs which
have been observed as medhya drugs and few others have shown to have definite action
on brain called as psychotropic drugs e.g.</span></div>
<ul style="text-align: justify;">
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Shankhapushupi<span style="mso-tab-count: 1;"> </span>-<span style="mso-tab-count: 1;"> </span>Convolvulus Pluricaulis choisy</span></li>
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Mandukharmi<span style="mso-tab-count: 1;"> </span>-<span style="mso-tab-count: 1;"> </span>Centella Asiatica</span></li>
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Brahmi<span style="mso-tab-count: 2;"> </span>-<span style="mso-tab-count: 1;"> </span>Bacopa – monnieri</span></li>
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Ashwagandha<span style="mso-tab-count: 1;"> </span>-<span style="mso-tab-count: 1;"> </span>Withania somnifera Dunal</span></li>
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Vacha<span style="mso-tab-count: 3;"> </span>-<span style="mso-tab-count: 1;"> </span>Acorus calamus</span></li>
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Jyotismati<span style="mso-tab-count: 2;"> </span>-<span style="mso-tab-count: 1;"> </span>Calastrus paniculatus</span></li>
<li><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Jatamansi<span style="mso-tab-count: 2;"> </span>-<span style="mso-tab-count: 1;"> </span>Nordostachys Jatamansi</span></li>
</ul>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">The drugs have a true tranquilizing effect on brain
without inducing any hangover or dullness of brain. These are helpful in
inducing sleep and freshness of brain for better performance, thus improving
the intellectual activity and memory also. These plants also help as to come
out of severe complexes, depression and antisocial trends e.g. suicide,
hemisuidal, homicidal etc.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">By their virtue of having effect on psychic they are also
effective for the management several psychosomatic disorders. Heart disease,
hypertensions peptic ulcer, ulcerative colitis are some of the notable disease
of this group. These drugs have also anabolic effect on general metabolism.
Cardio vascular drugs: cardio vascular disease is a great cause of mortality
like cancer in the western countries. But the developing countries are no more
exception. The incidence of high B.P., heart disease, and obesity is in
increasing in China and India. Usually the people have a feeling that it is
disease of affluent society and the treatment as only possible by the modern
drugs. But none of them is true; there is description of this disease in
Ayurvedic literature which is referred to be a contribution of 500 B.C. The
treatment of heart disease is still in practice in Indian system of medicine.
The effective drugs of cardiovascular system are as follows:</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Arjun <span style="mso-tab-count: 2;"> </span>:Teminalia Arjuna</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Gugulu <span style="mso-tab-count: 1;"> </span>:
Balsamodendron mukul</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Pushkarmula : Inulr Recemosus</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Shalpharmi <span style="mso-tab-count: 1;"> </span>:
Desmodium gangetiun</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Karbir <span style="mso-tab-count: 2;"> </span>:
Theretia Nereifolia</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Kutha <span style="mso-tab-count: 2;"> </span>:
Holerrbena – Antidysenterica</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Rasona <span style="mso-tab-count: 1;"> </span>:
Alliun – Sativum </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Thus a good number of cardio vascular drugs are in our
urmamentorium of medicinal plants which can be developed as potent drugs in
future.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Respiratory System:</span></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">According to Ayurveda respiratory system is the chief
site of Kapha hence the disease also produce the symptoms of Kakha. Vata is
also involved simultaneously in some disease as Bonchial Asthma. It is a well-known
fact that if is a disease having ofstruction branch opathy. Obstruction may be
because of the Oedoma/ inflammation of the mucosa or due to bronco –
construction, forma is allergic inflammation due to excess of histamine like
substances and the latter is because of the predominance of anticholenergic
substance. Allergic manifestatias may produce several symptoms of respiratory
tract disorder e.g. Allergic Rhinitis, Nasopharongitis Brynchitis etc. The
following drugs have been found to be useful for amelioration of the above
pathology.</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Tulsi :Olimum sanctum</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Sirisha <span style="mso-tab-count: 1;"> </span>:Albizzia Leffeck benth</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Kantkari<span style="mso-tab-count: 1;"> </span>:Solan um xanthocarpum</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Vasa <span style="mso-tab-count: 2;"> </span>:Adhatoda Vasca</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Madhuyasti <span style="mso-tab-count: 1;"> </span>:Curucuma
Longa</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;"></span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Sunthi <span style="mso-tab-count: 1;"> </span>:Zingiber Feivale</span></div>
<div class="MsoNormal" style="text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Bibhitaka <span style="mso-tab-count: 1;"> </span>:Terminalia Belerica</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Tulsi is supposed to be most pious plant in Indian
culture. No worship is complete without offering the tender leaves to God and
then same is distributed among the masses for beneficial effect on health. The
evidences are in favour that it is an immunostimulant thus providing increased
general resistance for the prevention of disease. It is antipyretic,
antinflamatery, expectorant and milid bronchodiloty thus of great help to the
patient of upper respiratory and bronchial disease. Sirisha is known as an
established drug for allergic disorders and branchal asthma. Charak has
described it to be most effective vishghna (antitoxic drug). On Pharmacological
study it is found to be antihistaminic and steroidogenc, plasma cortisol is
increased within a week after the administration of the drug Active Principle
is known to be a Saponin.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">All above drugs may be used alone or in combination for
the treatment of several types of respiratory system disease. Shirisadi
compounds containing Shirisha, Kanthari, vasa and Madhyuasthi is popularly used
as shiristi chey (tea). Sunthi.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Gastro
– Intestinal:</span></b><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;"> Statistics is evident that the incidence of
gastro intestinal diseases in India is maximum. Broadly these can be classified
in two groups (i) psychosomatic disease (ii) parasitic infection and a third
group can be idiopathic. Among the first group peptic ulcer (parionon shula)
irritable bowel syndrome and colitis are the common clinical entities available
in our country. Ion the second group amoebiasis, giardiass and other worm
infections are common e.g. round work, Hook worm, thread worm. There is a concept
of Jatharagni in Ayurveda. Apart from that it also seems to help the absorption
and metabolism. In case of hyperseoretion/Hyposecreation absorption becomes
poor and the metabolism registers at a lowereble. So the malsecretion and
malaobsoption syndrome are related to each other and produce several disease of
G.I. tract which are often known as adiopathic e.g. Amlaphita, graham etc.</span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">A
good number of drugs have been worked out and found to be useful for the
treatment of these disorders or follows :</span></div>
<div class="MsoNormal" style="margin-left: .5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Patola – Gastritis</span></div>
<div class="MsoNormal" style="margin-left: .5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Nurikela – Pepticulcer</span></div>
<div class="MsoNormal" style="margin-left: .5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">KLutaja – Colis</span></div>
<div class="MsoNormal" style="margin-left: .5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Karanj – Amoebiasis</span></div>
<div class="MsoNormal" style="margin-left: .5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Bilwa – Amoebiasis</span></div>
<div class="MsoNormal" style="margin-left: .5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;">Palas – Beeja – worm infections</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Most of these drugs stimulate and digestive and help in
regeneration of villi for a better absorption which leads to acceleration of metabolism.
Some of the drugs are proved to be antihelimenthic and antiparasitic others
offer symptomatic relief to the gastro intestinal symptoms. </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Liver Dis-function:</span></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">The most common disease of liver is infective hepatitis
(kamala) Though it is a fact that it is a self limiting disease and takes about
4 weeks to become alright but it has got a very deterimented effect on health,
if the pathology continues come residual symptoms perrists it may turn into
cirrhosis of liver which is fatel in due course of time.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Otherwise of the infection is fulminating it may take
acute turn and patient may pass towards acute hepatic failure characterized by
anasarca, hemorrhage, renal and curdic failure and the patient may succumb in
no time. </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Even in the normal course of the disease there can be
four stages on the first week there is no jaundice, there is fever and loss of
appetite and general weakness usually the cough and cold may be present with
the beginning of the process. In the second week Jaundice is marked urine, stool,
skin, nails, eyes everything becomes yellow, in the third week there may be
inflammation of file canaliculi colangitis leading to intrapepaic obstruction
and regurgitation of file in the blood producing a more deep Joundice and
whiteclay colourd stool, in the fourth week the pathology may resolve<span style="mso-spacerun: yes;"> </span>or pass to the stage of complication.
Otherwise also, it the resolution is not complete the lesion may perrist as
residual pepatitis. The following drugs hae been found to have a cholaratic
effect and helping in the complete resolution of hepatitis, so these drugs have
preventive as well as curative effect in patients of hepatitis.<span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"> </span></span></span><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;"> </span><br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Kalmegh
– Androgaphis panculata<span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"> </span></span></span><br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"> </span></span></span><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Bhringraj
– Eclipta alba</span><br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Amalaki
– Emblica officinalis</span><br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Sarpankha
– Tephrosia purpurea.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">In clinical trial all these drugs in combination or as
single drug can be used kalmegha and Amalaki combination are under clinical
trial in our medicinal plants unit serum bilirubin comes down to normal range
within to 2-3 weeks hepatitis is improved and there is no chance of having
residual hepatitis in the end.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">The discussion could be extended to any length but it is
concluded with an optimistic note that India with its rich heritage of herbal
medicine, its wealth of medicinal flora and necessary expertise in all relevant
area would be able to offer leadership in the development of herbal medicine. I<span style="font-family: "arial" , "sans-serif";">t</span>
should, however be kept in mind that tomorrows citizens of India will have a
better scientific temper and attitude and will not be satisfied to know merely
that it works they will question how it works? Our development should be
equipped to answer this questions.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Dhirendra V. Singh </span><b style="mso-bidi-font-weight: normal;"><span style="font-family: "arial" , "sans-serif"; font-size: 12.0pt; line-height: 115%;"></span></b></div>
</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-79977003964671132612014-02-25T03:10:00.001-08:002014-02-25T06:47:11.359-08:004th Anniversary of Genelife Clinical Research<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Not so long ago, on 26 Feb 2010 we
started Genelife Clinical Research, after years of planning and analyzing the
cost & expenses. On this day our dreams took-off with a lot of enthusiasm,
promise and hope in the back drop of recession and limited resources. We knew that
if we will survive that period we would have no limits. During those days we
had to survive not only the recession but also against mighty established
players. We survived that period and emerged as a winner in our own way. The
first year was a very emotional year. We had gone through lots of pain and
turbulence before we reached our 1st anniversary.</span><span style="color: black; font-family: "Arimo","sans-serif"; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin;"> </span><span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">But why I am talking about that
now.. because this was an equally challenging year. </span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">This year we will be remembering as the
year of “reform and regret”. Across the country the quality of care of patients
and clinical research was decreasing considerably. The necessary quality
standards were available as standard in some places and were unavailable in others.
Our regulation which was developed in a piecemeal fashion over a period of time
was not able to manage the things properly and industry was in desperate need
for reform- which finally happened this year. However, the planning, developing
and implementation of this reform took almost a year, which almost killed the
Clinical Research industry of India. Many competitor companies including some
giants pull their curtains down; some changed their mode of operations. This
changed the entire complexion of Clinical Research market, which to some extent
is positive because now only those seriously involved companies are left in
this serious business. </span></div>
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<br /></div>
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<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Everybody in healthcare industry was
affected by this “silent” phase and we were no exception. However, with the
confidence in our system and support of clients, friends and well-wishers we
came out of this period. This could have been even better if we would have not
lost some US FDA projects due to this regulatory complication. I still regret
that decision of taking those projects in such an unstable regulatory
environment. It was hard for us, but even larger concern and my deep apology to
those sponsors whose time, energy and money wasted during this tenure.</span></div>
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<br /></div>
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<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Since inception, Genelife Clinical
Research has focused on strong customer relationship with a vision "To be
the most respected partner in providing product development and clinical
research needs." The effort of giving the best is a kind of self-motivating
mantra which probably separates us from the rest. And probably this is the only
thing which helps us to emerge excellent from any given situation.</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Looking back at the development of
the entire year; it gives me a sense of achievement. We started the year on
high note and anticipated a greater growth; however, with all the hiccups, what
we achieved is remarkable growth not only in terms of project but also in terms
of reach. We now have a global presence and soon we will be operating globally.
We have implemented electronic CRF and looking forward to implement CTMS.</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">I would like to to attribute this
year’s success to my team, which stuck to the basics & kept me away from
taking any imprudent decisions. The secret of our success this year is not just
doing the right thing but doing the right thing in customer centric way cost
effectively. Very basic principle we understood our sponsor’s requirement and
planned according to their requirement. </span></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiVY5hyphenhyphendTqyPkR8ipSbKOARk5qRdh0PunvPQzz3sMb50KUSyJ1VcyQ5wufDWBZZ6kG18KTWiiDstxo_QKTjXcALdysu8U9NIrZP9RVZmJ2vv1stWT9vBukZVlPR3ySeiQky3foGHttzQJjR/s1600/IMG-20140225-WA0011.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiVY5hyphenhyphendTqyPkR8ipSbKOARk5qRdh0PunvPQzz3sMb50KUSyJ1VcyQ5wufDWBZZ6kG18KTWiiDstxo_QKTjXcALdysu8U9NIrZP9RVZmJ2vv1stWT9vBukZVlPR3ySeiQky3foGHttzQJjR/s1600/IMG-20140225-WA0011.jpg" height="240" width="320" /></a></div>
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<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">On this auspicious occasion, I sincerely
appreciate the faith of clients on our ability. We are looking forward to
deliver that trust in best possible way. I am greatful to all those who have directly
or indirectly helped us to shape our dream and vision. But my greatest thanks
to my colleagues and consultants for their commendable effort and believing the
ideology of Genelife Clinical Research. This year belong to them and I feel
proud to be a part of this excellent team.</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">I am looking forward for the same
kind of trust, faith and support from everyone in future. I know if we perform
this good, we will evolve even better in the coming year.</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<br /></div>
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<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Thank You.</span></div>
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<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Kind Regards,</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Dhirendra V. Singh </span></div>
</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com2tag:blogger.com,1999:blog-2937117122788051753.post-4947339940043830592013-11-29T06:55:00.002-08:002013-11-29T06:55:22.425-08:00Genelife Clinical Research: Ophthalmology Clinical Trials <div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEibRQoRcHjVtbfLJfbv3Al16DqImIquWD_c8ns6e58zNwrKo7cMKCxi2tOkJnjBIyBOC2jKpdgIWe-pkN2PWjn59LO7sJxACdxsUsM__W1GP0NAx-bO-Py2B2toV8SlanhpT2SQV6gZeG3R/s1600/Clinical+Research.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="132" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEibRQoRcHjVtbfLJfbv3Al16DqImIquWD_c8ns6e58zNwrKo7cMKCxi2tOkJnjBIyBOC2jKpdgIWe-pkN2PWjn59LO7sJxACdxsUsM__W1GP0NAx-bO-Py2B2toV8SlanhpT2SQV6gZeG3R/s200/Clinical+Research.jpg" width="200" /></a>Genelife Clinical Research has
started 12 Phase III Ophthalmology Clinical Trials for DCGI Submission. These
12 studies cover vide range of indications including dry eye, Ocular pain,
Intra Ocular pressure, different types of conjunctivitis, pre & post
cataract surgery etc. In these studies we are recruiting all kinds of patients
from minor to old age people which will be a challenging task for us.<span style="mso-spacerun: yes;"> </span></div>
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We have already finished
selecting sties for these studies. All the sites are selected very carefully as
per the current DCGI guidelines including audio visual regulation. All these
sites are multi-specialty/government hospitals with DCGI approved ethics
committees and are distributed in all Geographical regions of India. During
site selection we have considered seasonal variation as well as on recruitment
prevalence of the particular ophthalmic condition from DSR, historic data and
geographical location. </div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqYdC31p4dS95ax6rFa4gdLXrfJzsMKaIi5eWNdtl96b-J5RHC1qGxI27moLyVkjE13-2uPTwty2hVX8gNGW_QDRqKBUM0FFw386ePkUn6_WqMCLOJ5flDwhN8GR5YltkhR63qg3ILg4u7/s1600/Clinical+Research+2.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="141" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqYdC31p4dS95ax6rFa4gdLXrfJzsMKaIi5eWNdtl96b-J5RHC1qGxI27moLyVkjE13-2uPTwty2hVX8gNGW_QDRqKBUM0FFw386ePkUn6_WqMCLOJ5flDwhN8GR5YltkhR63qg3ILg4u7/s200/Clinical+Research+2.jpg" width="200" /></a> </div>
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For adapting and absorbing the
complexities aroused due the introduction of audio visual informed consent we
have developed our electronic CRF which will be able to capture that also. This
will help us to make a complete document for a patient for regulatory purpose
and future regulatory audit purpose. During the site selection procedure we
have made special emphasis on the infrastructure of site and computational
knowledge of site personal. </div>
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Like our past studies we are hoping to complete these study
before the time we proposed to our Sponsor. Hope we will achieve our target.
<br />
Kind Regards,</div>
<br />
<div class="MsoNormal">
Rama Rajesh </div>
<div class="MsoNormal">
Project Manager </div>
<div class="MsoNormal">
<b>Genelife Clinical Research </b></div>
</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com3tag:blogger.com,1999:blog-2937117122788051753.post-59728773630333316602013-02-26T04:09:00.003-08:002013-12-17T23:30:26.974-08:00Genelife Clinical Research: III Anniversary <div dir="ltr" style="text-align: left;" trbidi="on">
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We perform at our intellectual best and by exceptional willingness when we know why and what we're doing; with this motivation Genelife Clinical Research was established (on 26th Feb 2010). Every one related to Genelife either employees, clients, consultants, investigators, vendors or well-wisher they all have played their role most effectively and efficiently in the establishment & development of Genelife Clinical Research. On the third anniversary of Genelife Clinical Research I would like to thank everybody who has worked to achieve our goal “To be the most respected partner in providing product development and clinical research needs.” We can say this, because we have been haired more than once by all our sponsors. </div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvLezT5lhhAwY9JqTG7gw9tNxw7QPAMNWzI2nbkE57lS9dBm1XzL6pPvl1RShFxDAto50aMMgM7qSHTjHT_4MfdCjF8Zf9KFLbDdBFh1-hTdDTzfsNNoFJ-BNpb9zC-Jbxy6g6DbsCnJLG/s1600/2013-02-26+15.20.38.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvLezT5lhhAwY9JqTG7gw9tNxw7QPAMNWzI2nbkE57lS9dBm1XzL6pPvl1RShFxDAto50aMMgM7qSHTjHT_4MfdCjF8Zf9KFLbDdBFh1-hTdDTzfsNNoFJ-BNpb9zC-Jbxy6g6DbsCnJLG/s200/2013-02-26+15.20.38.jpg" width="200" /></a></div>
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The development of Genelife Clinical Research has proved that marketing and sales is not the only deciding factor for the development of an organization. Our continuous development is because of our young Operations & Biometrics team, which has shown the urge to reach their full potential in order to make each project successful. They proved that the strongest principle of growth lies in one’s choice. We were privileged to receive this choice from our esteemed clients who trusted in our capabilities and entrusted their important projects. Furthermore, our development is also credited to those clients who have given suggestions for process development in place of project, which was equally valuable. And with them we hope to strengthen our relation further. </div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi69utJeTYad0LehjVNasK6VSZuxB5kGL6G0X5g6iAqn8OPGHqROst3Czm7qC86UWbF1G3uQquFq08lywVVVFvfWUvJEDeAV-jz0mXlO_PyZxyyaMRX5Pj1U4ZYnnFzb_exlsNEEGfbNQNE/s1600/2013-02-26+15.25.35.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi69utJeTYad0LehjVNasK6VSZuxB5kGL6G0X5g6iAqn8OPGHqROst3Czm7qC86UWbF1G3uQquFq08lywVVVFvfWUvJEDeAV-jz0mXlO_PyZxyyaMRX5Pj1U4ZYnnFzb_exlsNEEGfbNQNE/s200/2013-02-26+15.25.35.jpg" width="200" /></a>Genelife Clinical Research has seen several notable changes this year like: </div>
<div style="text-align: justify;">
<ul>
<li>Web CRF </li>
<li>New & bigger office </li>
<li>Global presence; we now have major clients in Australia, Europe & North America. And now we have operations in Malaysia, Sri Lanka, Bangladesh, Indonesia and South Africa. </li>
</ul>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhb_10KtdObB4pleDjlwElxEdsw-FTCn1I1B_zCMZ2SkLDnrNvughpF0r2x_JNvHpjs73La1r4j3a2yZMe5v9KBEtzF9kMffNx6l6x9gA3KJnpmEmQNz_XDBjX_qDxqrZWa46bb9lQj5Mxc/s1600/2013-02-26+15.25.28.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhb_10KtdObB4pleDjlwElxEdsw-FTCn1I1B_zCMZ2SkLDnrNvughpF0r2x_JNvHpjs73La1r4j3a2yZMe5v9KBEtzF9kMffNx6l6x9gA3KJnpmEmQNz_XDBjX_qDxqrZWa46bb9lQj5Mxc/s200/2013-02-26+15.25.28.jpg" width="200" /></a></div>
In 4th year of our business we will focus on accelerating our growth strategy while continuing to build on the strength of our brand—by sharing the knowledge of our services & strength through effective marketing. However, we will not follow the conventional method of marketing also. It will be as unique as our “Disease Surveillance Report”. We are very excited about this and truly believe that this will bring a trend in our fraternity. This will also be our first step towards expansion with stability, better service, and global presence while still offering all advantages of a small size CRO. We are also very excited for our new office in Copenhagen which we will open in May 2013. However, our focus will remain on “Creating Innovation” in our project management implementation. </div>
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Looking back on the trails of time and development I feel proud to be a part of this exciting journey. This keeps me encouraged and intrigues me to reach further out to you, our partner, client and ambassador. </div>
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<br /></div>
<div style="text-align: justify;">
Thank you everybody. </div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
Kind Regards,</div>
<div style="text-align: justify;">
Dhirendra V. Singh</div>
<br /></div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com4tag:blogger.com,1999:blog-2937117122788051753.post-71873225746099795812013-01-27T13:31:00.001-08:002013-06-04T06:29:43.049-07:00Biosimilar Regulation in India <div dir="ltr" style="text-align: left;" trbidi="on">
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A biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product is known as Biosimilar.</div>
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This could be the single fastest-growing biologics sector in the next five years – albeit from a small base – spurred by the convergence of major dynamics that will see new biosimilars enter the US market, bring additional molecules to Europe, and open up oncology and autoimmune disease areas to biosimilars for the first time ever. Biosimilars also bring clear potential for payers in the emerging pharmaceutical or “pharmerging” markets, such as Brazil, China and India. India have developed new regulatory guidelines for Biosimilar.</div>
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In New guideline DCGI has made mandatory the preclinical evaluation of biosimilar. The non-clinical studies should be comparative in nature and design to detect differences if any, between the similar biologics and innovator recombinant product. These should be conducted with the final formulation of the similar biologics intended for clinical use, unless otherwise justified. The non-clinical study design may vary depending upon the clinical parameters such as therapeutic index, the type and number of indications applied for etc. Assays like receptor binding studies or cell based assays (e.g. cell proliferation assays) should be conducted, when appropriate to establish comparability of biological activity. In cases where invitro assays do not reflect the pharamacodynamics, in-vivo studies should be performed. Comparative repeat dose toxicity with immunogenicity testing is also made compulsory in given route of administration, local tolerance should be evaluated.</div>
<br />
<div style="text-align: justify;">
According to new guideline, comparative Pharmacokinetic (PK) study on healthy subjects, Pharmacodynamics (PD) studies in most patients or healthy volunteers. If PD marker is available in healthy volunteers, PD in healthy volunteers can be done. Followed by a Phase III, Comparative safety and efficacy in relevant patient population is also mandatory for all biosimilar. However, in certain cases it can be waived. DCGI has also mandated the submission of PSUR 6 monthly for first 2 years and then annually for next 2 years, along with a Post Market study.</div>
<br /><div style="text-align: center;">
<b>Regulatory applications and approvals issued at different stages of biosimilars product development</b></div>
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<b>No. <o:p></o:p></b></div>
</td>
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<b>Stage <o:p></o:p></b></div>
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<b>Agency involved <o:p></o:p></b></div>
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<b>Application<o:p></o:p></b></div>
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<b>
Approval<o:p></o:p></b></div>
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1<o:p></o:p></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: double windowtext 1.5pt; mso-border-top-alt: double windowtext 1.5pt; padding: 0in 5.4pt 0in 5.4pt; width: 149.35pt;" valign="bottom" width="199"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Manufacturing permission for test, analysis & examination<o:p></o:p></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: double windowtext 1.5pt; mso-border-top-alt: double windowtext 1.5pt; padding: 0in 5.4pt 0in 5.4pt; width: 102.65pt;" valign="bottom" width="137"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
DCGI<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: double windowtext 1.5pt; mso-border-top-alt: double windowtext 1.5pt; padding: 0in 5.4pt 0in 5.4pt; width: 63.05pt;" valign="bottom" width="84"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Not Spesific<o:p></o:p></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: double windowtext 4.5pt; border-top: none; height: 30.0pt; mso-border-bottom-alt: solid .5pt; mso-border-color-alt: windowtext; mso-border-left-alt: solid .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: thin-thick-small-gap 4.5pt; mso-border-top-alt: double 1.5pt; mso-border-top-alt: double windowtext 1.5pt; padding: 0in 5.4pt 0in 5.4pt; width: 126.8pt;" valign="bottom" width="169"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Permission (Manufacturing NOC)<o:p></o:p></div>
</td>
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<tr style="height: 30.0pt; mso-yfti-irow: 2;">
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: double windowtext 4.5pt; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: thick-thin-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 26.9pt;" valign="bottom" width="36"><div align="right" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: right;">
2<o:p></o:p></div>
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Manufacturing License for test, analysis & examination<o:p></o:p></div>
</td>
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Local FDA<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 63.05pt;" valign="bottom" width="84"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form 30<o:p></o:p></div>
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Form 29<o:p></o:p></div>
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<tr style="height: 45.0pt; mso-yfti-irow: 3;">
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: double windowtext 4.5pt; border-right: solid windowtext 1.0pt; border-top: none; height: 45.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: thick-thin-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 26.9pt;" valign="bottom" width="36"><div align="right" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: right;">
3<o:p></o:p></div>
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R & D<o:p></o:p></div>
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Institutional Biosafety <br />
Committee (IBSC)<o:p></o:p></div>
</td>
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Not Spesific<o:p></o:p></div>
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Permission<br />
(IBSC minutes)<o:p></o:p></div>
</td>
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<tr style="height: 15.0pt; mso-yfti-irow: 4;">
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4<o:p></o:p></div>
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Non-Clinical studies permission<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 15.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 102.65pt;" valign="bottom" width="137"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
RCGM<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 15.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 63.05pt;" valign="bottom" width="84"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form C3<o:p></o:p></div>
</td>
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Form C4<o:p></o:p></div>
</td>
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<tr style="height: 30.0pt; mso-yfti-irow: 5;">
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5<o:p></o:p></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 149.35pt;" valign="bottom" width="199"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Submission of Non-clinical study report<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 102.65pt;" valign="bottom" width="137"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
RCGM <o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 63.05pt;" valign="bottom" width="84"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form C5 <o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: double windowtext 4.5pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: thin-thick-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 126.8pt;" valign="bottom" width="169"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form C6<o:p></o:p></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 6;">
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: double windowtext 4.5pt; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: thick-thin-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 26.9pt;" valign="bottom" width="36"><div align="right" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: right;">
6<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 149.35pt;" valign="bottom" width="199"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Clinical Trials <o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 102.65pt;" valign="bottom" width="137"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
DCGI <o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 63.05pt;" valign="bottom" width="84"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form 44 <o:p></o:p></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: double windowtext 4.5pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: thin-thick-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 126.8pt;" valign="bottom" width="169"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Permission <br />
(CT NOC)<o:p></o:p></div>
</td>
</tr>
<tr style="height: 30.0pt; mso-yfti-irow: 7;">
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: double windowtext 4.5pt; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: thick-thin-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 26.9pt;" valign="bottom" width="36"><div align="right" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: right;">
7<o:p></o:p></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 149.35pt;" valign="bottom" width="199"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Manufacturing License for CT batches <o:p></o:p></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 102.65pt;" valign="bottom" width="137"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Local FDA (subject to CT NOC)<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 63.05pt;" valign="bottom" width="84"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form 30<o:p></o:p></div>
</td>
<td nowrap="" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: double windowtext 4.5pt; border-top: none; height: 30.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: thin-thick-small-gap windowtext 4.5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 126.8pt;" valign="bottom" width="169"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Form 29<o:p></o:p></div>
</td>
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<tr style="height: 30.0pt; mso-yfti-irow: 8;">
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Manufacturing & Marketing permission<o:p></o:p></div>
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Form 44<o:p></o:p></div>
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1. Form 45/46 (Finished product)<br />
2. Form 46A (Bulk product)<o:p></o:p></div>
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Commercial Manufacturing License<o:p></o:p></div>
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Form 27 D<o:p></o:p></div>
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Form 28 D<o:p></o:p></div>
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<span style="font-family: 'Times New Roman', serif; font-size: 11.5pt;">Kind Regards,</span></div>
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Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-27808744459042564672013-01-13T12:31:00.000-08:002013-06-04T06:35:34.707-07:00Genelife Clinical Research- Ongoing Medical Device Clinical Trials <div dir="ltr" style="text-align: left;" trbidi="on">
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Genelife Clinical Research has started its first Medical Device Pilot Clinical Study for US FDA submission. Although we have participated in couple of US FDA studies in past but both were Pharmaceutical Clinical Trials. This is first time we are going to start a Medical Device Clinical Trials for Medical Device, within ENT therapeutic area. </div>
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The study will be performed in a single site in India and we are hoping to recruit all patient volunteers in one month. The site selection procedure was dependent on not only the historic performance, type of Institute and its geographic location, paramedical staff, Investigator’s qualifications but we also considered the importance of patient referral. This we did considering the importance of project as well as the dependence of season on recruitment. </div>
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Like our past studies we are hoping to complete this study before the time we proposed to our Sponsor. Hope we will achieve our target.</div>
<br /><br />Kind Regards,</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com12tag:blogger.com,1999:blog-2937117122788051753.post-29154025168418847742012-11-26T01:43:00.000-08:002013-06-04T06:39:18.758-07:00Advantages of eCase Report Form <div dir="ltr" style="text-align: left;" trbidi="on">
No experiment is said to be complete until the results had been published or otherwise reported. It becomes even more important when the research directly involve human. Clinical research not only directly involves human subjects but can also affect human health if the reporting is not performed properly. And for proper reporting, proper data collection is very important.<br /><br />In 70% clinical trials data collection is done manually through paper CRF in which Investigators manually record data on source documents and copy the same to the CRFs. Clinical monitors from CRO/sponsor verify the data and send the CRFs to CDM team. Paper CRF usually has an audit trail that is visible directly on the CRFs. Changes to individual fields are indicated with a single-line cross out, with the changed data appended along with the signature or initial of the person making the change, a date and perhaps a reason for change. Comments are written in the margin of these CRFs. Data clarification forms are appended to the CRF and contain the questions and responses that generated the change. This time honored format creates a complete case record with audit trail that is familiar to regulatory reviewers and investigators.<br /><br />Though paper CRF gives an accurate, reliable and complete data, it is a laborious process and takes time for collecting CRF from investigational site, performing data entry and validation, and raising and resolving queries via Data Clarification Form (DCF). This has direct impact on time for drug to come in market. This suggested the idea of real time data management tools. Hence technology and innovation is used to its full extent and Electronic Data Capture (EDC) comes into limelight. The concepts for the design of electronic CRF are same as covered for paper.<br /><br />EDC technology is expected to improve efficiency and accuracy of data, speed up decision making process and reduce cost. It resulted in a reduction of paper consumption and load on clinical monitors to manage such huge volume of paper. This paradigm has reduced the risk of damage of CRF during transit. It is due to these reasons EDC is preferred to traditional method.<br /><br />GCP and 21 CFR Part 11 require validation for a software system used for processing clinical data. System validation includes user requirement specifications, functional specification, design specifications, implementation and testing. 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Part 11 has requirements to implement controls including audits, system validations, audit trails, electronic signature and documentation for software and systems involved in processing electronic data that are a) required to be maintained by FDA rules and b) demonstrate compliance to a predicted rule.<br /><br />In electronic CRF, investigator enters data and signs electronically for accuracy, reliability and completion of all data points. It assembles data from multiple tables into a single Web page. However, the investigator later can add, modify or delete data in the EDC system in future at any time-point, until the electronic CRF are locked and no more updating is permitted. Investigator at this point should sign for the changes made to electronic CRF data points which were entered or changed. At the end, Investigator has to sign for all data entries, modifications or deletions as he is owner of that clinical data. This is why signing by the investigator is so important in electronic data capture.<br /><br /><br />Audit trails and comments are not found in the margins of an eCRF- they are viewable through links from the CRF and also are simply user-friendly representations of data tables. Electronic CRF is not just a repository but is designed to allow the backend systems to perform efficiently. The forms have built in edit checks and no longer accept entered data. POPs will appear if there is any error in entry/incorrect value. Query management can be done within minutes as opposite to paper CRF. Queries can be managed through computer user interface rather than paper based clinical trial. We can raise query directly on website and monitor can log on the query message and provide his resolutions there. Since high quality data are available at the time of data entry by the study site, biostatistician can review and analyze very early. As a result almost all statistical programs are completed before the visit of last patient.<br /><br />Roles of data management staffs that have changed with the arrival of eCRF:<br /><ol style="text-align: left;">
<li>Data entry task shifted to site personnel/investigator </li>
<li>Data review/cleaning became a joint venture of site personnel/investigator, clinical monitor and CDM team </li>
<li>Trainer is needed in CDM to impact training functionality of EDC software </li>
<li>Clinical monitors to perform source data verification which is a QC task, </li>
<li>CDM members have to generate extra manual review listings and perform this task manually </li>
<li>Clinical monitors or data management team to address/resolve technical issues faced by site personnel/investigators. </li>
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However few challenges exist and researchers are trying to evaluate if quality of data produced by traditional paper based studies is better or equivalent compared to data generated by EDC. Investigational site personnel find data entry as a tedious task. Multiple EDC software has created confusion to non-CDM members. There is a need to develop effective training for EDC software, which is study specific for a given protocol. Hence investigational sites require technical support and guidance. One of the most common deficiencies cited by the FDA is the lack of documentation since the original observations are entered directly into a computer system; in this case electronic record becomes the source document. Paper is eliminated but EDC uses technologies like internet, software EDC and other additional services such as call center, so it cannot be considered as a cost-effective solution.<br /><br />There is no doubt that electronic data capture is the future as it increases the speed of data processing and assures high quality data with lower error than paper CRF of Clinical Research. However, deployment of these advances should be implemented carefully as it requires consideration of desired outcome and the needs of people involved in the process. <br /><br />Representing <br /><br />Genelife Clinical Research - Clinical Data Management Department<div class="MsoNormal" style="text-align: justify;">
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Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com0tag:blogger.com,1999:blog-2937117122788051753.post-54829686548125743962012-08-24T07:00:00.000-07:002013-01-16T04:33:38.280-08:00Patient Recruitment and Retention- Genelife Approach <div dir="ltr" style="text-align: left;" trbidi="on">
<span style="text-align: justify;">With recent times INDIA is booming as developing place for all the fields along with Clinical Research. Because of the large population and diversity India is one of the hot spot for clinical research at the global frontier. The population across country understanding the real health care need and the importance of drug discovery where the critical link is Clinical Research.</span><br />
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Clinical Development is the key milestone for a drug to get into the market shelf. Clinical Studies got vital role for better understanding of the discovered molecule activity in human and the subjects who are intended consumers of the drug. <o:p></o:p></div>
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For a successful drug launch the Clinical Studies and population participation is a demanding process which should happen for achieving the objectives of the drug utility and to provide best health care to save lives.<o:p></o:p></div>
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The connectivity of process and the prominent points of patient recruitment and retention;<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Clinical development phase initiation <o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Clinical Trials protocols development</div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Therapeutic Indications understanding<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Patient availability & assessments <o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Patient recruitment and retention strategies <o:p></o:p></div>
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Patients Availability and Assessments – The study design and the indications were the base to engage and assess the patients availability and assessments must be done on the basis of:<o:p></o:p></div>
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<span style="font-family: "Courier New"; mso-fareast-font-family: 'Courier New';">o<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Ethnicity<o:p></o:p></div>
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<span style="font-family: "Courier New"; mso-fareast-font-family: 'Courier New';">o<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Demographics<o:p></o:p></div>
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<span style="font-family: "Courier New"; mso-fareast-font-family: 'Courier New';">o<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Geographic<o:p></o:p></div>
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<span style="font-family: "Courier New"; mso-fareast-font-family: 'Courier New';">o<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Incidence and Prevalence<o:p></o:p></div>
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Advertising programs brings attention about the research happening and ignites intentions for connecting population to participate in the research. The healthier and understandable advertising with proper methodologies really brings branding for the drug as well. Across globe the concept of medical research and the potential risks and benefits has to be socially publicized through media by having regulatory intimacy.<o:p></o:p></div>
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The consistent advancements through ethical research for establishing bliss for humanity through medicines and participated population and the benefits received by them by value and appreciation must be taken forward into society and public by media. These kinds of steps will enhance awareness across communities for contributing into research and development.<o:p></o:p></div>
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Patient retention throughout the study is the most important task and it can be achieved by the classic methodologies and the intimacy of Investigator and site team plays vital role to achieve maximum retention rate. <o:p></o:p></div>
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Patient retention is possible with; GENELIFE CLINICAL RESEARCH methodology<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Simple explanation of the study and the milestones of it<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Clear and complete understanding about the patient importance and expectation from them<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Explaining the potential benefits risks and facts about the study and their role with intimacy in terms of health, reimbursements (travel & meal) and making patient comfortable at clinic<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Whom to contact if patient is having any questions or concerns and being available at any time accessible for patients.<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Make patient clear about quit procedures and its implications and results.<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Make them feel appreciated and valued as they were critical contributors for the research<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Consistent interaction with patients and follow up.<o:p></o:p></div>
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Patient recruitment is possible with; GENELIFE CLINICAL RESEARCH methodology.<o:p></o:p></div>
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Focus groups- the population eligible for study participation. Identifying focus groups and finding the communities through available data resources.<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Communicating and engaging different critical disease communities across the globe by accessing the GP’s and various organization and independent disease surveys making GENELIFE CLINICAL RESEARCH potential with subject availability.<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>The <a href="http://www.genelifecr.blogspot.in/2010/12/significance-of-disease-surveillance.html">DSR – Disease Surveillance Reports </a>across different horizons with floating life standards and various conditions based survey is making GENELIFE CLINICAL RESEARCH understand the proximities of disease prevalence.<o:p></o:p></div>
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<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span>Building extensive relationships with research organizations, institutions, academic labs, hospitals, clinics and medical fraternity with ethical research oriented intention is paving way to access patient pool for desires indications across therapeutic indications.<o:p></o:p></div>
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These steps improving the Clinical research employing potential, to move on with best patient recruitment and retention strategies for accomplishing the study primitives.<o:p></o:p></div>
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GENELIFE CLINICAL RESEARCH employs such methodologies with global outreach to provide compendious clinical development solutions <span style="background-color: white; color: #000099; line-height: 13.5pt; text-align: justify;"> </span></div>
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<span style="color: #000099;">Regards,</span></div>
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<b><span style="color: #002060;">GENELIFE CLINICAL RESEARCH</span></b><o:p></o:p></div>
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Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com4tag:blogger.com,1999:blog-2937117122788051753.post-58636959627425140442012-07-03T04:50:00.002-07:002013-11-05T06:10:49.221-08:00Project Management Approach<div dir="ltr" style="text-align: left;" trbidi="on">
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Genelife Clinical Research is among one of the few CRO’s who have adopted Project Management Approach. This model widely helps us conserve timeline and cost. This model is predominantly devised from and for complex studies like cancer, cardiology clinical trials, but it can be retrofitted to other therapeutic areas. The basis of this model is the disease surveillance study which we conducted across India to study the trends of diseases.</div>
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Clinical Research industry demands quality data in most cost effective manner, we have designed Genelife Model. Industry trends and patterns have changed due to economic slowdown which suggests cost effective research and CRO can be best partner to achieve the same. </div>
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In this model we have taken the Clinical Research process as a system and we identify exact input with well-defined process to bring effective output. The first input comes from Study Feasibility Analysis (SFA) Site Feasibility analysis (SFA); due to available disease prevalence data this process has become very fast and cost effective for us. This procedure is conducted on the basis of initial Project Plan (PP).</div>
<br /><br /><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMVFSuP8l2RlmWry_8d-XPA2zIi_VO9Z4ziDcsLDN4TWyqqMo-kN6QccJ1y8B5MgqcuuL7l1VR0KrZ5xgFAbZBeQBu7GqbqUy-K9D7XScO0M94l59vKN0gDxV_aUqy2rOgLJNJ66SWywY8/s1600/project+management.png"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMVFSuP8l2RlmWry_8d-XPA2zIi_VO9Z4ziDcsLDN4TWyqqMo-kN6QccJ1y8B5MgqcuuL7l1VR0KrZ5xgFAbZBeQBu7GqbqUy-K9D7XScO0M94l59vKN0gDxV_aUqy2rOgLJNJ66SWywY8/s320/project+management.png" /></a><br /><br /><div style="text-align: justify;">
Study & Site Feasibility Analysis (SFA): Genelife Clinical Research has feasibility which works under Project Management Team. This team understands the objectives of the study and provides the solution to main question of project like what to be done; how to be done; at what cost; in what time. During site feasibility we emphasize on site not only with high disease prevalence but also with clinical research supportive environment. Clinical Research supportive environment is very important aspect for physician referral and it is not considered most of the time. </div>
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Project Planning (PP): in our model we have divided Project planning in two major parts. In 1st is for initial phase is for training and performing initial activity like feasibility. After receiving the feasibility reports we develop plans like risk management plan, communication plan, QA plan, safety plan, monitoring plan, Data management Plan, SAP plan etc for stating how to complete a project within a certain timeframe, usually with defined stages, and with designated resources. In totality the plan will include setting quantitative objectives, identifying deliverables, identify & manage foreseen and unforeseen risk, overcome bottleneck planning the schedule and making supporting plans.</div>
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Project Management & Commencing: Once a project moves into the Execution Phase, the project team and the necessary resources to carry out the project should be in place and ready to perform project activities. The project team handover the activities to different departments and start analyzing the progress of work. </div>
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Last stage of this model is suitable output which is directly dependent on above two steps. As per Genelife Model, with precise inputs and efficient process, one tends to get desired output in terms of faster regulatory approval, quality data, shorter timelines and better return on investment.</div>
<br />Representing<br /><br />Genelife Clinical Research – Project Management Department</div>
Genelife Clinical Research Private Limitedhttp://www.blogger.com/profile/11629403351808356531noreply@blogger.com1