White papers & guides30 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
White papers & guides18 September 2025 FDA’s Draft Guidance on Overall Survival The FDA’s August 2025 draft guidance reshapes oncology clinical trials by requiring pre-specified overall survival (OS) analysis in... 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
