The authorities then asked for further clarifications about certain procedures. Step II involved providing the replies to the questions that were raised and taking corrective actions wherever necessary, within a given timeline. Step III was a two-day site visit by two auditors from the US. They interacted with our staff and researchers, including the ethics committee members and everyone involved in the research process. They also did a random sample check of various documents requested by them. Post auditing, there were minor observations, for which we had to take corrective action (step IV) and then, finally we got the approval. The entire process took little more than a year.

What are some of the steps taken by JCDC to set itself apart from other CROs in India?
Since we started in 2006, we have set ourselves apart by setting up a one-of-its-kind research center. We are situated within the hospital premises and we have committed infrastructure and people to focus on research. Besides, sponsored clinical research from pharma companies and CROs, which consists largely of phase II and III studies; we conduct investigator initiated research that is basically original research.

Please tell us about some of the recent achievements of JCDC in the CRO domain?
We work with nearly all the top 10 pharma companies worldwide. We had awarded the best clinical research investigator site in 2010 by the Indian Society of Clinical Research. We are also ISO 9001 certified. We have diversified into the education space by setting up a training center. We also do medical writing work, monitoring, and data management for some of our clients. We don't position ourselves as a CRO but we have capability of doing CRO work and can provide end-to-end services. However, our main focus still remains on providing high quality site management services.

What are your plans for the future?
We are serious about clinical research and want to grow in this field. We are tying up with hospitals for providing site management services in India and abroad. We have also set up a dedicated research laboratory and are looking to grow our training division to create more branches in India.