Synchron Research Pvt Ltd, a leading contract research organization in the country has teamed-up with Symogen a UK-based pharmacovigilance company for effective implementation of Pharmacovigilance activities and set up an independent unit for commencing the services in India for the first time in the country. The company has also entered into a strategic partnership with the US-based Parexel International to monitor clinical trial sites in India, Malaysia, Nepal, Sri Lanka and Pakistan.
The Rs 6-crore Ahmedabad-based Synchron commenced its operations in Bangalore two years ago. “The facility in Bangalore will conduct phase II to phase IV studies and investment of around Rs 1 crore has been made to install the software and hardware including MedDRA and WHO dictionary to speed-up its clinical research and data management studies” said Dr. Shivprakash, managing director, Synchron Research Services Pvt Ltd.
As a first step on its association with Symogen, Synchron had organized a one-day seminar on Pharmacovigilance in Bangalore for clinical investigators, pharma companies, regulatory affairs personnel, academicians and pharmacists to apprise on the recent developments.
Symogen team is here in India to train the staff at Synchron for causality assessment, coding and statistical analysis. Symogen will bring in their strengths of pharmacovigilance services to India through Synchron, stated Dr. Arun Biswas director, Symogen.
Synchron in India, offers clinical registration of new pharmaceutical products and medical devices, from phase I to phase IV, including Bioequivalence, Bioavailability, Pharmacokinetic/Pharmacodynamic studies, Statistical Analysis and Data Management strictly adhering to ICH and GCP guidelines. It also provides clinical trial services to domestic and international pharmaceutical and biopharmaceutical companies.
The US-based Parexel plays a key role in clinical development services for pharmaceutical biotechnology and medical device industry to help clients to reduce the time to market development control costs.