Global Presence: Bridging Continents in Clinical Research

 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.

Why Our Global Presence Matters

Local Expertise, Global Reach: 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

Meeting Regional Needs: 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. 

Streamlined Communication: 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.

Reduced Time to Market: 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.

Our Multifaceted Approach

Strategic Collaborations: 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.

Regulatory Expertise: 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.

Quality Control: Maintaining the highest standards of quality is non-negotiable. Our global presence means that rigorous quality control measures are implemented consistently across all regions.

Patient-Centric Focus: 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.

The Genelife Advantage

Our global presence isn't just about having offices in multiple locations; 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.

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.

Empowering Innovation in Drug Discovery and Development: Genelife Clinical Research

 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.

Our Aim:

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.

Tools of Success:

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:

 

Electronic Data Capture System: 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.

 

eDocumentation System: 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.

 

Project Management Software: 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.

 

Central Randomization Software: 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.

 

Technologically Strong and Transparent:

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.

 

ICH E9 Complaint Analysis & Reporting: 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.

 

Centralised Monitoring: 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.

 

 

Multi National Presence: 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.

 

Partnering for Success:

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.

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.

Contact us today, and let's embark on a partnership that redefines the future of healthcare.

BA/BE Services

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.

Site Selection Services:

Expertise Assessment: 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.

Regulatory Compliance: We ensure that selected sites adhere to all relevant regulatory guidelines, including Good Clinical Practice (GCP) standards, ethical considerations, and local regulatory requirements.

Logistics and Resources: We carefully evaluate the availability of facilities, equipment, and resources required for sample collection, analysis, and data management, ensuring seamless study operations.

Site Management Services:

Quality Assurance: Genelife Clinical Research establishes a robust quality assurance and quality control system to monitor site performance, data accuracy, and protocol compliance throughout the study.

Training and Certification: We provide comprehensive training and certification for site personnel to ensure they fully understand and adhere to standardized procedures and protocols.

Data Collection and Management: We implement state-of-the-art data collection and management systems, including electronic data capture (EDC) solutions, to maintain data accuracy and integrity.

Adverse Event Reporting: Genelife Clinical Research develops and enforces clear protocols for the reporting and management of adverse events and safety concerns, prioritizing participant safety.

Project Management Services:

Comprehensive Project Planning: We create detailed project plans that encompass timelines, milestones, budgets, and resource allocation for every phase of study, from site selection to data analysis. 

Risk Mitigation: Genelife Clinical Research identifies potential risks and proactively develops mitigation strategies to address any issues that may arise during the course of your research.

Effective Communication: Our team maintains open and transparent communication channels among all stakeholders, including sponsors, regulatory authorities, research sites, and contract research organizations (CROs).

Budget and Timeline Management: We meticulously manage project budgets and timelines, ensuring efficient resource allocation and adherence to project milestones.

Documentation and Reporting: 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.

Quality Control: We enforce continuous quality control measures to guarantee that your study is conducted in strict compliance with relevant regulations and standards.

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.

 

Genelife Clinical Research Ventures into Ulcerative Colitis Research!

 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.

A Glimpse into Our Journey:

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.

Why This Matters: 

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.

Our Approach: 

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.

What Lies Ahead: 

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.

Stay Tuned: 

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.

Thank you for joining us on this exciting path towards scientific discovery and improved patient outcomes. Together, we can make a difference.

Drug Resistant Tuberculosis

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.

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.

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.

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.

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.

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.

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.

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.

The pipelines for new diagnostics, drugs, treatment regimens and vaccines are progressing, but slowly. Increased investment in research and development is needed.

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 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.

#mdrtb #tuberculosis #antituberculosis #drugs #hiv #tb #treatment

6th Anniversory

History of Clinical Research Regulation in India

All regulatory bodies has the responsibility to provide access to the safe, effective and quality, medication to their people.  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.

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.

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.

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)).  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.

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.

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.   

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.

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.

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.

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.

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.

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.

DCGI further amended the policies for to improve the quality of clinical research. It took three years to design this:

• Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical;
• The Ethics Committees will have to be registered under DCGI
• Investigators are limited to working on a maximum of three trials simultaneously;
• 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;
• 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;
• 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;
• Consideration of new drug applications will take into account ethnic differences in metabolism etc.;
• 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
• Manufacturers, sponsors and CROs are advised to provide compensation for any drug-related anomaly detected at a later stage.
• 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. 

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.