Partnerships in Clinical Trials Asia Pacific: Strategies for Successful Site Evaluation

Dr. Narendera Maharaj, General Manger, Global Clinical Operations, Glenmark Research Center, India

Why is it important to have the right site selected?
Site selection: Key elements to look at
-Speed
-Quality
-Cost

At the end of the day, it’s critical the both the sponsor and the CRO agree to what they select.

It is not important to have a database of investigators, what they need to know is that they have sites that they are comfortable with in terms of speed and quality. They need to have sites that they’ve had good experiences working with them. Look at a comprehensive of all of the sites you’ve selected, and find out what works best with you. You must plan, a CRA must do all of the homework before going to the site. It can all be done in house.

What does someone do as part of the site selection visit? One needs to prepare, do things at site, and have post visit follow up.

At the site visit, you must allow investigators to ask the right questions. They could be both general and study specific questions. For example, it could be about your patient recruitment and your safety requirements. At the end of the day one of the real questions is if the conductor has the interest to do the investigation properly.

There are now software analysis that will help you predict a site’s performance. It could be very helpful in selecting the right sites. Benchmark for your sites according to your own experience are critical for beneficial benchmarks.

After having a round of site evaluation experiences, do a benchmark on the information from the sites. Come up with a way to rank the sites.