Yearly Archives: 2024

Today, large academic research centers receive the vast majority of trial opportunities, leaving countless other sites constrained by studies that don't align with their strengths. It’s not uncommon for experienced and motivated sites to accept the majority of opportunities that come their way, even when it's not the best match for their team and patients. This results in highly qualified sites underperforming across trials – not because they lack the ability to deliver results, but because they lack the power to be strategic and selective in choosing trials.

Many site personnel, upon assuming responsibility for a new eRegulatory system, may not immediately recognize that, in addition to managing access credentials, the U.S. Food and Drug Administration now requires compliance with the guidelines outlined in the owner’s manual, specifically addressing electronic records and signatures as per 21 CFR Part 11 in the Code of Federal Regulations.

Topics highlighted include diversity and inclusion, decentralized clinical trial (DCT) elements, workforce challenges, and a possible role for sponsors and contract research organizations (CROs) in supporting outreach by sites based in diverse communities.