US-based contract research organisation (CRO) Kendle has approval from the Indian authorities to set up an operations centre within a Special Economic Zone (SEZ) in the Ahmedabad-Gandhinagar Knowledge Corridor.

The new facility, which is expected to be up and running by mid-April, will be a “high-end, world-class centre of excellence” focusing on the quality delivery of clinical data management, medical writing, pharmacovigilance/safety, biostatistics/programming and other services related to knowledge processing, Kendle says.

These clinical support services will be integrated under one roof, providing “an efficient operations hub for the region”, the CRO adds. The SEZ operations centre will initially house around 50 associates and is expected to scale up to some 300 associates in the near term.

It is also positioned to expand further “very quickly if necessary to meet customer demand”, Kendle notes. The unit’s proximity to multiple universities and the city of Ahmedabad gives it access to “a vast untapped talent pool ideal for building an expanding a high-tech workforce”.

With a population of more than 1 billion, a “growing and improving” research infrastructure, an “efficient and evolving” regulatory framework, favourable intellectual property laws, a large pool of medical professionals and established research credentials, India is “quickly becoming a world power in clinical research”, Kendle comments.

Analysts predict that by 2012, more than 65% of all trials regulated by the Food and Drug Administration will be run outside the US, while the Indian CRO market is expected to witness growth of 49% per year, the company observes.

Kendle already operates throughout the Asia-Pacific region from offices in Ahmedabad and New Dehli, India; Beijing, Hong Kong and Shanghai, China; Kuala Lumpur, Malaysia; Bangkok, Thailand; Manila, the Philippines; and Sydney and Melbourne, Australia.