BMS outsources safety monitoring to India

pharmafile | September 14, 2007 | News story | Sales and Marketing India, safety 

A team of 140 people based in Chennai, India, is to help Bristol-Myers Squibb monitor safety and side-effect reports from its drugs, in what is thought to be one of pharma's first outsourcing of pharmacovigilance work.

Pharmacovigilance, the monitoring of drug safety data, is such a core discipline in pharma that few companies have considered outsourcing the work to third parties, but BMS have now signed a deal with Accenture to provide the service.

The new multi-million dollar deal reflects two significant trends – the increasing need to monitor drug safety in the post-Vioxx world, and the expansion of outsourcing using India's cheap, but high-quality, workforces.

The Chennai centre will not replace the BMS's own in-house pharmacovigilance, but will rather run in parallel to it. The Accenture team in India will process and code adverse-event data, produce reports on regulatory and safety issues, and aggregate reviews made by doctors of adverse events observed in patients.

The companies claim this is the first collaboration for 'end-to-end' safety case processing, including such specialised activities as medical review of reported adverse reactions.

"Building a joint team with a specialised focus will support the continued growth of our robust product pipeline, improving scalability and increasing overall productivity," said John Balian, head of global pharmacovigilance and epidemiology at BMS.

"Working with Accenture, Bristol-Myers Squibb will continue to access world-class talent to deliver on our regulatory obligations, while enhancing our focus on patient safety."

The pharmacovigilance centre is part of Accenture's Life Sciences Centres of Excellence in Bangalore and Chennai that Bristol-Myers Squibb already utilises.  

Leading companies are re-thinking their operating model to drive sustainable growth and productivity, said Eric Sandor, managing director of Accenture Pharmacovigilance Services.

"Through a truly collaborative partnership with Bristol-Myers Squibb, we have established an industry leading operation that is delivering substantial efficiency and improved flexibility for Bristol-Myers Squibb's pharmacovigilance organisation."

Part of a multi-year R&D agreement signed in April 2007, BMS says the pharmacovigilance centre collaboration is an indication of its drive to expand its R&D capabilities in India and a general representation of  the company's overall global strategy.

 

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