Navigating the Post-EU CTR Reality: 5 Takeaways from Veeva Summit

Jul 08, 2026 | Matt DeFranco

Biopharmas still struggle with ownership models, country-level requirements, and poor system interoperability under the EU Clinical Trials Regulation (CTR).

From managing regulatory complexity to Clinical Trials Information System (CTIS) limitations, here are five key topics disclosure leaders discussed at Veeva’s recent R&D and Quality Summit.

#1. Prepare for manual CTIS workflows as the EMA prioritizes stability

The European Medicines Agency (EMA) is prioritizing operational reliability and core CTIS modules over new innovation.

A key challenge is the lack of bidirectional API functionality between CTIS and sponsor systems. Because the EMA is unlikely to overhaul these APIs before 2028-2029, sponsors and CROs must prepare for heavily manual workflows.

#2. Leverage structured data for CTIS preparation

Without bidirectional APIs, managing data governance across TMF and RIM systems is resource-intensive and error-prone. Simple document misclassifications create major compliance and confidentiality risks.

Sponsors can mitigate this by pulling structured data directly from CTMS to auto-populate disclosures. This replaces manual entry risks with accurate, pre-packaged PDFs ready for CTIS upload.

#3. Bridge the gap between clinical operations and regulatory affairs

Silos between clinical operations and regulatory affairs cause process disconnects and ambiguous CTIS ownership. With health authorities requiring responses within 48 hours, organizations must unify workflows to meet RFI timelines.

Connecting start-up documentation with RIM data gives teams real-time visibility into protocol changes for faster turnaround times.

#4. Anticipate IVDR as the next major regulatory risk

In Vitro Diagnostic Regulation (IVDR) requirements are already active, even though the European Database on Medical Devices’ portal won’t launch until late 2026 or 2027. This gap forces organizations to navigate fragmented local ethics processes.

Additionally, IVDR performance studies do not map cleanly to existing clinical and regulatory architectures. Sponsors anticipate this will become an operational hurdle over the next 12-24 months.

#5. Put redaction and AI on your roadmap

Managing commercially confidential information is a massive administrative drain. Veeva is tackling this burden by introducing platform-level redaction and expanding the integration with Real Life Sciences (RLS) anonymization tools.

Looking further ahead, context-aware AI initiatives with Veeva Falcon will support SOP-driven automation and interpret evolving confidentiality rules.

Want to keep up with changing disclosure requirements? Veeva Disclosures is expanding support beyond ClinicalTrials.gov and CTIS to include Japan, the UK, Germany, and China. These improvements help teams manage evolving global requirements from a single, unified ecosystem.