At the Veeva R&D and Quality Summit, we spoke with Steph Viscomi, Head of TMF at Apellis Pharma, about how sponsors can strengthen site relationships through transparency, streamlined documentation, and lean TMF practices.
Viscomi emphasized that sites want to feel like part of the sponsor’s team—not vendors, and that communication gaps often erode trust and slow study momentum. She shared that some sites even keep a “naughty list” of difficult sponsors, underscoring the need for more collaboration and empathy in sponsor–site relationships.
Discussing TMF practices, Viscomi highlighted that many CROs still struggle with eTMF adoption, despite its clear advantages in auditability, efficiency, and quality. She noted that paper-based systems are a thing of the past, and that giving monitors continuous access—rather than limited 48-hour windows—improves transparency and audit readiness.
She also introduced the concept of a lean TMF, which focuses on collecting only essential, meaningful records that tell the story of a trial. This approach reduces volume and workload while improving focus and collaboration.
Viscomi urged the industry to reduce site burden by streamlining processes, improving system access, and fostering open communication. “Audit readiness,” she said, “isn’t a one-time effort—it’s a mindset of transparency and partnership.”
This content is sponsored by Veeva Systems
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
