Fast Tracking Study Start-Up from Site Selection to First-Patient Enrollment

At the 2020 Veeva R&D Summit, Amy Abernethy, MD, PhD, principal deputy commissioner and acting CIO of the FDA, said innovation happens at "the intersections" where "voices at the table represent different backgrounds, disciplines, and ideas." Spreadsheets are the predominant way sponsors and CROs manage study start-up, and others use applications for clinical trial management systems (CTMS) and electronic trial master files (eTMF) (see Figure 2 on facing page). The path to modernizing study start-up begins with identifying areas of improvement, mapping out processes, evaluating systems, and implementing change-management techniques proactively.