Best practices sharing: Setting up a professional clinical research unit in India.

The Drug Controller General of India has recently come up with very stringent laws to tighten the regulatory framework around clinical trials. One-way of improving the credibility of India and its researchers in the eyes of the regulators, sponsors and the general public is through professional site management team or setting up clinical research unit (CRU). The CRU acts as a bridge between the sponsor and the investigator. The CRU model has been better explained with the help of a good example of a clinical research institute. Since, a successful clinical trial needs high quality data, timeliness and clear communication between all parties, a professional CRU with a team of dedicated and trained professionals and infrastructure with written procedures and policies may be a solution to the pain and agony of poor site performance and investigator insufficiency and pressure.