Waltham, Mass.-based contract research organization (CRO) Parexel International has opened a major clinical operations and data management office in Hyderabad, India. The office will serve as the company’s main hub in the region and will expand its presence in the emerging Indian clinical trials market. Although Parexel already operates an 86-bed phase I unit in Ahmedabad, through a joint venture with the CRO Synchron, this would be the company’s first late phase clinical operations office in the region.

During the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta, Mark Goldberg, M.D., president of clinical research services and Perceptive Informatics at Parexel, discussed the company’s news with CWWeekly.

“One of the biggest challenges in running clinical trials today is patient recruitment and retention,” said Goldberg. “India provides a great opportunity to work with a vast population of patients, many of whom are interested in participating in clinical trials. Parexel will also be able to leverage its global footprint to perform appropriate tasks within a lower cost structure, such as data management.”

The phase I sector in India remains comparatively soft due to regulatory requirements on first-in-man studies. Goldberg stated he didn’t see that changing anytime soon but added that India will be a key later phase market for the company. About 7% of Parexel’s revenue comes from trials in Asia. And that business is projected to grow rapidly over the next few years. The U.S.-based consulting firm McKinsey has estimated that biopharmaceutical sponsors will spend $1.5 billion per year on clinical trials in India by 2010.