Building a Scalable Clinical Foundation at Intercept Pharmaceuticals

At the Veeva R&D Summit, we spoke with Bill Wallace, CIO of Intercept Pharmaceuticals, about the company’s work to build a modern clinical data foundation capable of scaling with operational demand.

Wallace emphasized that Intercept’s turning point came when each CRO was operating its own trial repository, creating delays, duplicative migrations, and limited visibility for Intercept’s clinical teams. He noted that this fragmentation left teams “behind the eight ball” in accessing data. Intercept responded by shifting to a unified Veeva Clinical Platform, ensuring data control, governance, and real-time access from the start of each study.

Discussing the impact on clinical operations, Wallace highlighted how shared access to timely data enables teams to identify site issues earlier and collaborate more effectively with CRO partners. This shift has strengthened oversight in alignment with emerging expectations under ICH E6(R3), and Intercept’s parent company, Alfasigma, has now adopted the same platform for its own trials.

He also introduced Intercept’s pragmatic approach to AI, rejecting the “one giant data lake” philosophy in favor of focused, use case driven data environments. Wallace explained how curated, fit-for-purpose “data lakes” allow the company to maintain validated datasets while enabling customized AI agents to operate securely and effectively. “You can’t put validated and unvalidated data in the same place and expect it to work well,” he said.

Looking ahead, Wallace urged the industry to prepare for a regulatory learning curve as agencies define the role of real-world data and hybrid models in rare disease research. “There is a lot that can be done and should be done,” he noted, calling for continued clarity on how such evidence will be evaluated.

This content is sponsored by Veeva Systems.