ACT Brief: Real-World Data Access Expansion, eSource Implementation at Scale, and FDA Regulatory Setback for Oncolytic Therapy

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• Thermo Fisher's PPD business entered a strategic collaboration with HealthVerity to gain enterprise-level access to claims data covering over 270 million de-identified patient lives. The partnership integrates taXonomy claims data with 70+ curated datasets to improve site selection precision, accelerate study startup, and strengthen AI-driven analytics across trial feasibility and real-world evidence generation.

• In a new video interview, Nick Frenzer, general manager of site solutions at Veeva Systems, discussed why eSource implementation has remained fragmented despite years of promise. FHIR-based API standards and a site-owned platform approach reduce integration work from hundreds of hours to fewer than ten, freeing site staff time to focus on patients rather than duplicative data entry and operational burden.
• Replimune received a second FDA complete response letter for RP1 in combination with nivolumab for advanced melanoma, despite prior breakthrough therapy designation and Phase II data showing 34% response rate. The company raised concerns about regulatory inconsistency and lack of agency engagement during resubmission review, indicating the setback may prompt workforce reduction and scaled manufacturing operations.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.