The Buzz

Author: Ferdous Al-Faruque
FDA News
March 18, 2013

Christine Pierre is the Founder, President and CEO of RxTrials, an investigative site network. She recently formed the Society for Clinical Research Sites (SCRS), the first industry group of its kind.

WDL: Last year you formed SCRS, what do you hope to achieve through the organization?

SCRS is committed to providing a voice and community to global clinical research sites. We have already, in our short four-month tenure, been approached by most of the major working groups involved in addressing the many issues within the clinical research ecosystem. Including the site’s perspective is now viewed as critical, because as we know many of these initiatives being discussed will ultimately impact the sites.

SCRS provided the first response from the clinical research site community to recent requests by the FDA for comments on two draft guidance documents, one which dealt with reviewing the qualifications of investigators, adequacy of research sites and the determination of whether an IND/IDE is needed and another guidance on electronic source data in clinical investigations. While some may view this as a small task, understanding that for the first time sites collectively came together, considered their response and provided their perspective on two guidance documents that will have a direct impact on sites is in our opinion a significant milestone for sites.

WDL: What are your priorities for SCRS this year?

Our next commitment is to continue to advocate on behalf of sites at various public and private meetings and speaking and writing to the global community. SCRS will make available its membership database to sponsors and CROs seeking sites. Our database includes the standard information about the site’s capabilities one would expect, but we go beyond that to report past enrollment metrics and FDA audit experiences.

WDL: What are some of the biggest regulatory initiatives SCRS is taking on or planning to take on?

In 2013, SCRS will be providing its members with assistance in developing compliance programs. It is our goal that all sites have a compliance program to help ensure human subject protection and the production of quality data. However, while sites may have the best intentions in wanting to have such a program, we know that such projects require resources. Therefore, the need for changes in the manner of how business is expected to be conducted, specifically with regard to payment terms to the sites, will also be an issue we will continue to address.