Clinical research or Clinical trials is any investigation on human (healthy or sick) that determines the safety and effectiveness of medicines, equipment, diagnostic products and or treatment regimens. They can be used for disease prevention, treatment, diagnosis or relief of symptoms. An intense network of activities and participants are involved in the clinical research ecosystem. During this unprecedented time of COVID-19, the best path to tackle the virus is a vaccine or an entirely new therapy. Recently, we have often heard about vaccines being developed at research centers and also heard about the different kinds of trials going on. These trials are performed in Clinical Research Organizations (CROs), like Genelife Clinical Research, a CRO head office based in Mumbai, India. Presently, Genelife Clinical Research is also involved in the development of a drug for Corona Virus.
Genelife Clinical Research was established in 2010, and is committed to providing drug development services to pharmaceutical, biologics, nutraceutical and medical device companies globally. With extensive Phase I-IV clinical trials facilities in Europe, the United States of America and Asia.
THE DEVELOPMENT OF GENELIFE
Genelife is created by a small community of like-minded entrepreneurs with grand ambitions and goals. However, things didn’t turn out according to their plans and hopes, and Mr. Dhirendra Vikram Singh (Managing Director) was the only one left by the end of the 2nd quarter. During that crucial period, he got stable support from his new business partner of Mrs. Himali Chaturvedi, and that was probably the real beginning of Genelife Clinical Research.
After initial challenges,the regular business was established towards the end of 2010 through Genelife Clinical Research (GCR). Markedly, Genelife was able to acquire two clinical trials for US FDA submission by the end of 2010. While Genelife’s first study drug got marketing approval (India) in 2012. In addition, Genelife diversified into pre-clinical research in 2012 and in 2014 Genelife Clinical Research conducted 1stGmbH submission study. Importantly, Genelife submitted got the first in human clinical trials for submission to the US FDA in 2015. Also, the first TGA submission study was performed by Genelife in 2016. After the success of the GCR, Genelife Clinical Research Pvt. Ltd. (GCRPL) was incorporated in 2015to continue the further work.
To announce its global presence, Genelife Clinical Research started its European operation with Genelife Clinical Research UnipersonalLda. Along with that Genelife has started branch offices in the United States, Germany and the United Kingdom in 2018.
Today Genelife provide services for the management of clinical research & BA/BE study like project management, creation of procedures, selection and management of clinical sites, clinical and medical tracking, data management, biostatistics, medical writing, regulatory consulting / support, audits, SEC presentations and meetings, pharmacovigilance studies, pre-clinical studies, and many more. Besides, legislative, project management, site management and monitoring services related to BA / BE studies are also offered.Introduction of E-Documentation System, Electronic Data Capture (EDC), Project Management Software and Central Randomization Software transformed Genelife Clinical Research into technologically efficient and transparent in service. With technology and a rigorous procedure, Genelife can provide its customers with the best quality through the excellence of their work.With project management being the core competency, Genelife always completed the project within timeline and resources. Further, with strategically located four branch offices, Genelife is in a position to offer efficient global service.
Moreover, with diverse experience inthe field of drug discovery and development,Genelife Clinical Research is in a unique position to pride all criteria for drug discovery and development under one roof. Their talented technical and operations team can successfully handle any drug research, pre-clinical and BA/BE projects, and this has always been the institution’s distinguishing characteristic feature.
ACHIEVEMENTS
Customer loyalty is the greatest accomplishment, unlike any company, customers are Genelife’s most significant accolades, they believe both items are intertwined. Many of the clients of the Genelife Clinical Research are repeated clients for which they feel very proud. Besides, Genelife has recently won the Indian Achievers’ Healthcare Excellence 2020 Award.
Mr. Singh says they are pleased with Genelife’s development from a four-person start-up to a medium-sized global CRO. Genelife has successfully completed/conducting 50+ clinical trials so far.
THE VISION OF THE FOUNDER
Mr. Singh’s got attracted to the field of research and the necessary process of drug discovery at Molecular Hematology & Oncology Research Institute, Muenster, Germany. He returned toIndia with the hope to develop Europe likeinfrastructurefor drug discovery and development in India. After gaining exposure in the Indian pharmaceutical industry, he decided to pursue his vision in drug discovery and development.
Mr. Singh’s next goal was to set Genelife Clinical Research on a global platform as the Indian pharmaceutical industry is a market dominated by generic drugs. Therefore, the scope of creation of CROs that only operate in India is minimal. The US and European CROs lead the global clinical research industry simply because most of the innovations are primarily centered on these continents. Because of the lack of international presence in terms of drug innovation in India, even the top Phase II-IV CROs of Indian industries are not Indian. With that in mind, Genelife is pushing for global operations of its own. In this respect, they have already established offices in strategically positioned areas in Asia, Europe and the United States.
Mr. Singh credits his performance to proactive towards opportunities, favourable outcomes, and persistence over and over. He claims that honesty, morality, and transparency are respected by clients, and hence, is most valued at Genelife.
Speaking of the issues and challenges, Mr. Singh says their work is directly related to the human health sector, and any negligence or mistake in research can affect millions of lives during and after the analysis is carried out. Therefore, due to its human care history, every step-in clinical research at Genelife Clinical Research is equally tricky and rewarding. “Inculcating the global regulatory requirement in the standard operating procedure is the most difficult aspect for Genelife, and finance has been a big challenge since the beginning,” says Mr. Singh.
FUTURE PROSPECTS
Genelife Clinical Research is already in business for over 10 years and has been in constant touch with many big companies like Pfizer, Osmotica, Peddock Laboratories, Reckitt Benckiser, CF Pharmtech, IntexTest, Aceto, etc., for various services in India. So, presently our main objective is generating awareness/recognition about our Global Presence and excellent facilities of our organization. The proximity with clients based in Europe, UK and USA will allow us to access market easily. Also, Genelife Clinical Research is building an infrastructure so that we can use the patient base of CIS, Africa, Middle East and Latin America. However, we will be 1st focusing on completing a global project so that the Genelife can develop to its full potential and reach newer heights.
Over and above, Genelife is now eager to diversify and expand into contract manufacturing.
