Site-Relationship Strategy: Ensuring Quality Data And Study Performance

By Lori Buckenmyer, inSeption Group

Strong relationships between a sponsor’s CRO and its clinical sites are instrumental to study success by any metric: ensuring patient safety and privacy, meeting ambitious timelines, assembling thorough documentation packages along with others. The lynchpin of such productive relationships is the CRO personnel assigned to manage and monitor sites — called CRAs or monitors, but referred to at inSeption Group as Regional Site Managers (RSMs).
Clinical sites generally expect a monitor/CRA to act as the study conductor, working with them to ensure high-quality data capture and the completion of relevant documentation. inSeption strives to go above and beyond in this role, wherein clinical sites can rely on their RSMs to shoulder a multitude of responsibilities, empowering each site to concentrate on treating patients. Critically, engaging an adept RSM before study start-up allows sponsors to reap maximum benefit from that individual’s expertise and effort.
Whether a site has lots of experience in clinical trials or very little, collaboration with a RSM during the selection process will provide transparency within site responses and sponsor expectations. If the site is struggling to provide answers or provides an answer that does not seem feasible (based on the site’s resources or personnel), the issue can be caught and addressed prior to study implementation, rather than corrected through remediation later. The RSM’s presence prior to initiation also eliminates the transition from study startup teams to a CRA or a monitor.
inSeption’s goal is to foster a relationship where sites look forward to a monitor’s insight and assistance, building a familial relationship versus a transactional one through a process rooted in kindness, flexibility, and understanding.