Insight Briefs30 October 2025 Implications of Assessing Overall Survival in Oncology Studies The FDA’s August 2025 draft guidance reshapes oncology clinical trials by requiring pre-specified overall survival (OS) analysis in... Learn more
Insight Briefs30 September 2025 Automated Evidence Generation for Regulatory-Grade Real-World Data Manual data abstraction can’t keep up with new FDA and EMA RWE standards. This whitepaper explains how automated... Learn more
Blog24 September 2024 Unlocking FDA’s Vision for PRO Collection in RWE: Timing, Methods, and Insights Discover FDA's guidance on collecting PROs for Real-World Evidence (RWE), focusing on timing, methods, and improving data quality. Learn more
Webinar FDA’s Vision on PRO/eCOA Collection for RWE: Timing and Methods Explained Watch back as our panel of experts discuss how the FDA views the collection of patient-reported outcomes for... Learn more
Blog9 August 2024 5 Key Takeaways from the FDA’s Real-World Evidence Guidance A deep dive into the evolving regulatory environment, the innovative approaches emerging in RWE, and the critical importance... Learn more
Blog9 May 2023 Unlocking the power of Real-World Evidence in FDA submissions An avalanche of data from so many real-world sources is available today, with the promise of more data... Learn more
