Division of AIDS (DAIDS), part of the US-based National Institute of Allergy and Infectious Diseases (NIAID), is joining hands with PPD Inc., a US-based global provider of discovery and development services and products for pharmaceutical companies, to facilitate clinical research management in India.

Research areas will include treatments for AIDS in adult and paediatric patients, strategies to prevent disease transmission, including mother to child transmission, and development of vaccines.

PPD will provide direct labour support based in the regions. The projected total value of the contract is approximately $245 million, of which an estimated $43 million would be subcontractor costs.

“PPD will work with DAIDS and its other contractors to facilitate clinical research management that integrates work being carried out by both clinical network and non-network systems, which include existing trial networks as well as individual investigators in US, Europe, South America, South Africa, Australia, China, Thailand and India. Details regarding specific countries within Asia in which clinical research will be conducted in connection with this contract is yet to be determined,” a spokesperson from PPD informed.

Recently PPD had been awarded a five-year contract from NIAID to support their activities in eight regions of the world including India. NIAID is part of the National Institutes of Health (NIH), an agency of the US Department of Health and Human Services.

PPD’s specific activities in connection with this contract will be guided by NIAID. We anticipate that we will need to add more staff to support our Asia facilities, including global coordinators, medical staff, project managers, trainers and legal and IT specialists. It is yet to determine which countries and in what proportions this additional staff will be assigned, he added.

The North Carolina-based PPD has nearly doubled its manpower resources as well as presence in Asia over the past year. Its operations in India and Korea alone contributed to a nearly 30 per cent increase in staffing across the continent within the first half of 2005.

During February last year, PPD had opened its office in Mumbai to provide patient recruitment and clinical monitoring for Phase II – IV studies with Samir Sadekar, manager of clinical operations, as its helmsman.

PPD’s services in India include patient recruitment, feasibility, trial monitoring and management, and regulatory support for clinical trial applications and marketing submissions.

When asked about the reason behind PPD’s foray into Indian contract research segment, the PPD spokesperson said, large populations that are increasingly located in dense urban settings, regulatory reforms and the presence of English-speaking clinicians have made India a targeted market for clinical research.