Biopharmas still struggle with ownership models, country-level requirements, and poor system interoperability under the EU Clinical Trials Regulation (CTR).<\/p>\n
From managing regulatory complexity to Clinical Trials Information System (CTIS) limitations, here are five key topics disclosure leaders discussed at ³Ô¹Ï±¬ÁÏ’s recent R&D and Quality Summit.<\/p>\n
The European Medicines Agency (EMA) is prioritizing operational reliability and core CTIS modules over new innovation.<\/p>\n
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.<\/p>\n
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.<\/p>\n
Sponsors can mitigate this by pulling structured data directly from CTMS to auto-populate disclosures<\/a>. This replaces manual entry risks with accurate, pre-packaged PDFs ready for CTIS upload.<\/p>\n 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.<\/p>\n Connecting start-up documentation with RIM data gives teams real-time visibility into protocol changes for faster turnaround times.<\/p>\n 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.<\/p>\n 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.<\/p>\n Managing commercially confidential information is a massive administrative drain. ³Ô¹Ï±¬ÁÏ is tackling this burden by introducing platform-level redaction<\/a> and expanding the integration with Real Life Sciences (RLS) anonymization tools.<\/p>\n Looking further ahead, context-aware AI initiatives with ³Ô¹Ï±¬ÁÏ Falcon will support SOP-driven automation and interpret evolving confidentiality rules.<\/p>\n#3. Bridge the gap between clinical operations and regulatory affairs<\/h2>\n
#4. Anticipate IVDR as the next major regulatory risk<\/h2>\n
#5. Put redaction and AI on your roadmap<\/h2>\n
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