At the 2025 Veeva R&D and Quality Summit in Madrid, Matt DeFranco, Senior Director of Disclosure Strategy at Veeva Systems, outlined the growing challenges sponsors face with EU Clinical Trial Regulation (EUCTR) compliance—and how technology is reshaping disclosure management.
DeFranco emphasized that EUCTR introduces significant complexity for sponsors. Beyond simply treating it as a regulatory submission, disclosure impacts clinical operations, regulatory affairs, and legal teams. Tight timelines, document redactions, and cross-functional alignment are proving especially difficult at scale. Without a centralized process, sponsors risk errors, delays, and public scrutiny once data is published on the EU Clinical Trial Information System (CTIS).
To address these hurdles, Veeva has launched Veeva Disclosures, a centralized application designed to simplify and standardize compliance. Fully integrated with Veeva’s clinical platform, the solution connects seamlessly with CTMS and eTMF, eliminating reliance on spreadsheets and third-party trackers. “It’s really a game changer,” DeFranco noted, highlighting automation, workflow management, and quality controls that ensure documents are reviewed, approved, and audit-ready before submission.
The approach goes beyond efficiency gains. By unifying study data, timelines, and documents in a single repository, sponsors gain oversight dashboards that improve transparency and reduce the risk of outdated or incorrect versions being submitted. Automated workflows and validation rules create consistency across submissions, while built-in redaction processes protect both confidential company data and personally identifiable information.
DeFranco underscored that disclosure is not only a regulatory requirement but also a matter of public trust. Patients, researchers, and regulators expect accurate, up-to-date information. Veeva’s centralized oversight allows sponsors to meet those expectations with confidence, while aligning processes to respond quickly to health authority questions and updates.
“Moving away from point solutions and fragmented integrations toward a unified platform is really the future of disclosure management,” DeFranco concluded. “With everything in one place—data, documents, workflows, and quality checks—sponsors can handle EUCTR requirements more efficiently, transparently, and at scale.”
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.
