UCB’s Shift Toward Smarter Oversight: From Fully Outsourced to CRO Agnostic

“Oversight is sometimes seen as a negative thing or a challenge, but with the new regulation you could almost see it as an opportunity to build on what you have, optimize, all for the betterment of patients.”

- David Appel, CSM Team Lead, UCB

At the Clinical Oversight Forum in Copenhagen, leaders from UCB and Veeva shared real-world lessons from UCB’s iHome journey, and why a hybrid, CRO-agnostic approach can deliver greater flexibility, transparency, and value for patients—especially in rare disease trials.

Discover:

  • The limitations of fully outsourced studies that pushed UCB to rethink oversight and operating models (00:27)
  • How becoming CRO-agnostic created flexibility across processes, people, and platforms (01:54)
  • Why rare disease trials accelerated the move toward in-house study management and deeper site engagement (02:08)
  • The biggest challenges in transitioning from hybrid models to a fully internalized operating model—and how UCB navigated them (04:08)
  • Why R3 oversight isn’t “plug and play,” and how sponsors can turn regulation into an opportunity for smarter outsourcing (09:30)
  • Practical change-management insights for sponsors considering new oversight models (11:46)