• Nermeen Varawalla.
• PRA International, Pacific House, Imperial Way, Reading, Berkshire, RG2 0TD, UK. varawallanermeen@praintl.com
• Idrugs. 2007 Jun 1; 10 (6): 391-4.

AbstractBacked by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.

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