Sachin Jagdale – Goa
The facility is spread across 40, 000 sq ft area on a total plot size of 3.5 acre in a private industrial park. The 100-bed unit has departments of bioanalytical, clinical research, regulatory affairs, pharmacovigilance and data management, a fully functional ICU and pathological testing centre for conducting Bio Equivalence and Bio Availability (BABE) studies.
Dr Nitin Borkar, Founder Partner and Chief Executive Officer, VerGo Pharma Research, said, “Complete development solution, from concept to approval can be provided with VerGo Clinicals.”
Clinical trials are one of the most critical steps in the expensive drug discovery programmes and also helps generic pharma companies establish bio equivalence over the innovator products. The data generated from the study would determine the future regulatory approval for their drug or formulation.
High speed, high quality data and accessibility to the required quantum of sample size are of prime importance for any CRO. It is crucial to have the GxP compliant facility, qualified experienced staff and the right volunteer pool. VerGo Clinicals has team members with versatile experience, having national and international regulatory environment exposure.
VerGo Clinicals has already started its operations. The facility has diverse volunteer database. With a capacity to cater six to nine BABE projects a month and also take up late phase clinical studies. VerGo Clinicals is targeting compliance to global regulatory agencies like US FDA, MHRA, MCC and TGA.