GlaxoSmithKline Pharmaceuticals Limited, India today announced the company plans to expand its clinical trial data management, analyses and reporting activities based in Bangalore significantly. The CDMA operations working on global development projects has today moved to a new office in order to offer better work environment as it readies itself for future growth.
Speaking to the media, S Kalyanasundaram, Managing Director, GSK India and Vice President, South Asia, GSK International, said, "GSK is pioneer in bringing high value added data management and analyses activities to India as far back as in 1996 - much ahead of others". He further added, "Our experience of the past nine years is highly positive. This has prompted us to shift these activities to larger and better premises with a view to facilitate their expansion."
The data management and analysis activities are conducted by Clinical Data Management Centre, India (CDMCI) set up in 1996 and Biomedical Data Sciences India (BDSI) started in 1999. The Bangalore Operations were set up as a centre for data entry for the Company's global clinical activities. These Operations grew in stature and importance, and increasingly so after the merger which created GlaxoSmithKline. This Centre now caters to the data services for global clinical trials conducted by GSK.
CDMCI is the first MNC data services outfit in the country to provide full business process services for clinical trials from protocol development through data management, analysis and reporting, to manuscript writing. The data entry unit of the operations has handled over 2.2 million subject data sheets since it started operations. Over the past nine years, CDMCI has provided clinical operations support to 400 clinical trials for the vaccines business of GSK. Recently CDMCI played a significant role in data management of one of GSK's largest ever clinical trials involving over 63,000 subjects around the world for a new vaccine against gastroenteritis. The Centre delivered clean and validated data for analysis within record time.
Speaking on the occasion, Dr Kwasi Amfo, Head, CDMCI, said, "GSK needs highly competent graduates and post-graduates from medical and technical fields as Programmers, Biometricians, Clinical Data Reviewers and Scientific Writers for these tasks. The highly educated, trained and specialised pool of talent available in Bangalore offers us these skill-sets. This has allowed us to expand our services to include activities in the Life Cycle Management portfolios."
BDSI co-located with CDMCI in 2001 post the GSK merger. It became a part of GSK India in 2004. The Group has worked on GSK's proprietary research molecules in therapy areas like CNS, CVS and metabolic disorders. To date, the Group has supported more than 100 clinical studies of pharmaceutical products of GSK plc.
BDSI is currently supporting 36 pharma studies for GSK worldwide including three large cardiovascular trials for a new compound involving over 13,000 subjects. Some of BDSI current projects involve working on drugs for NDA applications as well as Phase II trials for asthma and CNS. Besides these, the Group has reported studies from early phase development for the Company's own research molecules for treating metabolic disorders and cardiovascular diseases.
Dr Ashwini Mathur, Senior General Manager, BDSI, comments, "Cost advantage initially provided the necessary impetus to start Biomedical Data Sciences Operation in Bangalore, whereas other strategic advantages including differences in time zones, unique work culture highly conducive to value added IT services and mathematical / statistical abilities contributed to its growth."