ACRP Fellow David J. Morin, MD, FACP, CPI, FACRP, reflects on how bringing stakeholders together around a shared purpose can reduce inefficiencies, improve collaboration, and help clinical research better serve patients.
I first became a CRC in 2004, and I love my job. But there is a part of being a CRC that no one talks about enough: the mental weight of always having so much in motion.
For clinical research sites, manual data entry remains a substantial burden that drains resources and increases study timelines. This impact is worsening as clinical trials become increasingly complex, with more endpoints, procedures, inclusion/exclusion criteria, and data sources.
New approaches are required to comply with the ICH E6(R3) guideline for Good Clinical Practice (GCP), intended to drive a culture of quality. These include new ways of working, use of proportionate risk-based methods, and a culture that favors quality and rewards critical thinking.
Across the clinical research ecosystem, one truth continues to surface: time to activation matters more than ever. Delays in study start-ups don’t just slow recruitment. They shorten enrollment windows, frustrate investigators, and can ultimately determine whether a site remains competitive for future trials. Yet despite years of attention, many organizations still struggle to consistently activate studies within industry expectations.