Consulting and outsourcing specialist Accenture has built on an existing partnership with Bristol-Myers Squibb (BMS) to launch “the pharmaceutical industry’s first joint centre for pharmacovigilance” in Chennai, India.

The pharmacovigilance operation will be part of the Life Sciences Centers for Excellence run by Accenture in Chennai and Bangalore, India. BMS already makes use of these facilities under a multi-year research and development agreement signed by the two companies last March.

That included support for BMS’ clinical data and document management, pharmacovigilance and scientific writing functions in India. At the same time, BMS announced plans to set up a drug discovery and early development facility in Bangalore in collaboration with India’s largest biotechnology company, Biocon.

The new pharmacovigilance centre will be operated by more than 140 Accenture employees, who will process and code adverse-event data and generate periodic and aggregate safety reports for regulators as well as medical reviews of adverse events for physicians. “This is the first time a collaboration for ‘end-to-end’ safety case processing has been established and is inclusive of specialised activities,” Accenture noted.

The team in Chennai will be organised as “a parallel process and extension of Bristol-Myers Squibb pharmacovigilance headquarters’ operations,” the consultants added. “It allows for the seamless handling of data and reports between Accenture and Bristol-Myers Squibb while not compromising patient safety.”

The pharmacovigilance centre also marks a further advance in BMS’ efforts to expand significantly its R&D capabilities in India as an integral part of the company’s global strategy, Accenture pointed out.

Under pressure

With pressure to improve R&D yields and the increasing regulatory emphasis on safety in drug development, outsourcing of pharmacovigilance is a natural extension of other moves by Big Pharma to tap into emerging markets as a research base. “Leading companies are rethinking their operating model to drive sustainable growth and productivity,” commented Eric Sandor, managing director of Accenture Pharmacovigilance Services.

Accenture is no stranger to this phenomenon. In 2000 Wyeth teamed up with the consultants for a wide-ranging programme to re-engineer its R&D organisation. To capitalise on the resulting productivity gains, Wyeth needed also to improve its clinical data management capabilities. Encouraged by the success of the partnership, the company took the radical step of putting all of its clinical data management operation in Accenture’s hands for the next 10 years.

The consultants created a separate entity for this purpose, the Alliance for Clinical Excellence, which included centres in the US and Europe as well as some 400 employees in Bangalore.