Genelife Clinical Research: Ophthalmology Clinical Trials

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. 

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.

 

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.

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.
Kind Regards,

Rama Rajesh 

Project Manager 

Genelife Clinical Research

Genelife Clinical Research: III Anniversary

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. 

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. 

Genelife Clinical Research has seen several notable changes this year like: 

• Web CRF 
• New & bigger office 
• 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. 

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. 

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. 

Thank you everybody. 

Kind Regards,

Dhirendra V. Singh

Biosimilar Regulation in India

A biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product is known as Biosimilar.

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.

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.

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.

Regulatory applications and approvals issued at different stages of biosimilars product development

No.	Stage	Agency involved	Application	Approval
1	Manufacturing permission for test, analysis & examination	DCGI	Not Spesific	Permission (Manufacturing NOC)
2	Manufacturing License for test, analysis & examination	Local FDA	Form 30	Form 29
3	R & D	Institutional Biosafety Committee (IBSC)	Not Spesific	Permission (IBSC minutes)
4	Non-Clinical studies permission	RCGM	Form C3	Form C4
5	Submission of Non-clinical study report	RCGM	Form C5	Form C6
6	Clinical Trials	DCGI	Form 44	Permission (CT NOC)
7	Manufacturing License for CT batches	Local FDA (subject to CT NOC)	Form 30	Form 29
8	Manufacturing & Marketing permission	DCGI	Form 44	1. Form 45/46 (Finished product) 2. Form 46A (Bulk product)
9	Commercial Manufacturing License	Local FDA	Form 27 D	Form 28 D

Kind Regards,

Genelife Clinical Research- Ongoing Medical Device Clinical Trials

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. 

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. 

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.

Kind Regards,