Author: Ferdous Al-Faruque
FDA News
PALM SPRINGS, Fla. — Sites used the Oct. 12-14 Site Solutions Summit here to launch a global trade group, saying it will “amplify” their voice in discussions with sponsors, CROs and other clinical research stakeholders.
“Someone told me … if you’re not at the table, you’re on the menu,” said Christine Pierre, president of the Society for Clinical Research Sites (SCRS). “We’re going to be at the table talking.”
One of SCRS’ main goals will be to increase sites’ influence in clinical policy. “Many of the [global] regulatory agencies put out requests for comments on various draft guidance documents, and we want to insure that sites’ voices are represented in these types of documents,” Pierre said.
The group hopes to hire a global law firm by the end of the year to represent it on public policy matters, and has already brought on board Mark Lacy, founder of Benchmark Clinical Research, to co-chair a public policy committee.
Issues SCRS hopes to address include creating efficiencies in clinical trials, decreasing costs, working on site payment terms and shortening the timeline it takes to get products to market.
In addition to advocacy, SCRS will serve as a forum for tackling site concerns, connect members across various sectors of the industry and mentor new sites, Pierre said.
SCRS also plans to launch a quarterly peer-reviewed journal early next year. InSite will focus on articles that deal with “creating efficiencies, establishing best practices, and reinforcing those best practices with operational tips and tools for the clinical research site community,” Pierre said. She hopes the publication will also help other industry stakeholders understand some of the underlying problems sites face.
Pierre will continue as president of RxTrials, a clinical research site and organizer of the Site Solutions Summit, but will devote all of her time to SCRS, she said. RxTrials Chief Operating Officer Adam Chasse will assume Pierre’s responsibilities at the site. SCRS will also organize the Site Solutions Summit, which will become its annual meeting.
Full membership is limited to clinical research sites, but sponsors and CROs can join SCRS as associate members. This will give them access to certain information, such as running queries on previous clinical research data to evaluate sites.
Learn more about SCRS at www.myscrs.org. — Ferdous Al-Faruque