At the Veeva Clinical Oversight Forum in Copenhagen, we spoke with David Appel, CSM Team Lead at UCB, and Waseem Awad, Development Excellence Consulting Leader at Veeva, about how evolving regulatory expectations are reshaping sponsor operating models.
Appel emphasized that UCB’s shift away from fully outsourced phase 3 studies was driven by lived experience. He noted that full outsourcing often limited visibility into study execution, creating delays and blind spots in performance. That realization prompted a strategic move toward strengthening internal systems and oversight, supported by a more integrated CDMS and closer collaboration with partners. “You lose insight when everything is outsourced, and that insight is critical to decision-making,” he said.
Discussing R3, Appel highlighted how the guidance reinforces continuous sponsor oversight rather than retrospective document checks. The transition from essential documents to essential records requires sponsors to rethink how data, metadata, and decisions are captured and governed. Awad added that this shift is less about compliance theater and more about operational maturity, arguing that R3 creates an opportunity to optimize how sponsors work with CROs.
They also introduced UCB’s iHome model, an internally streamlined operating framework that evolved in phases. Initially designed to support rare disease studies with highly specialized sites, iHome prioritizes early site engagement and flexibility while allowing UCB to remain CRO agnostic. That adaptability, Appel explained, is essential in a competitive environment for both sites and patients.
Looking ahead, both urged sponsors to resist the idea of a plug-and-play R3 solution. “All models are wrong, but some are useful,” Awad said, underscoring the need for sponsor-specific interpretations grounded in people, process, and platforms.
This content is sponsored by Veeva.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
