Sponsors and contract research organizations (CROs) hoping to stand out in the crowd and attract the “best of the best” sites would be well advised to keep the lines of communication wide open before, during, and after a clinical trial.
“Some studies have provided us with FAQ spreadsheets–the spreadsheets where they track questions regarding the protocol and procedure–[and] this has helped us immensely when answering questions and providing preemptive information preventing deviations,” says Heather Wright, a clinical research coordinator at the Tampa Bay Clinical Research Center and member of the Clinical Researcher Editorial Advisory Board.
For Wright, sponsors and CROs making that kind of proactive effort score big points early. In the case of the FAQ spreadsheets, “it is not necessarily something we read monthly, or were expected to, but it was valuable to save time on communication with project staff.” It was also evidence that the sponsor or CRO “got” how to work with the site.
Wright’s observations track with the findings of “Becoming a Sponsor or CRO of Choice,” a new survey report from the Association of Clinical Research Professionals and The Avoca Group. It advises CROs and sponsors hoping to attract the highest quality sites to “commit to provide sites with clear, concise, and timely communication and be available and responsive to questions and/or concerns.”
It’s particularly important for CROs to excel in this arena, according to David Vulcano, LCSW, MBA, CIP, RAC, vice president for research compliance and integrity at HCA, Clinical Services Group.
His advice to CROs hoping to retain high-quality sites: “Start with the last negotiated contract with that site instead of sending out the usual template as if we have never worked together,” he says.
“Initiate and support phone conferences for issues in the [clinical trial application] after round one instead of the back and forth of the redlines multiple times,” Vulcano adds. “If it involves a sponsor decision, let the site talk directly to the sponsor.”
Author: Michael Causey
White Paper: Site Perspectives on Becoming a Sponsor or CRO of Choice
The white paper contains recommendations for sponsors and CROs who want to become “partners of choice” with sites.
Findings from research conducted by The Avoca Group are presented, including 4 key takeaways for building positive relationships with sites.