Management consultants Accenture and US drug major Bristol-Myers Squibb have launched what they say is the pharmaceutical industry's first joint center for pharmacovigilance in Chennai, India, for the monitoring of safety data and reporting of potential drug side effects.
Operated by more than 140 Accenture employees, the new center will undertake the processing and coding of adverse event data and the generation of regulatory periodic and aggregate reports on safety as well as physician medical review of adverse events.
This is the first time a collaboration for "end-to-end" safety case processing has been established and is inclusive of specialized activities, such as medical review of the reported adverse reactions. The team is organized as a parallel process and extension of the B-MS pharmacovigilance headquarters' operations. It allows for seamless handling of data and reports between Accenture and the drugmaker while not compromising patient safety.
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