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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The FDA’s August 2025 draft guidance reshapes oncology clinical trials by requiring pre-specified overall survival (OS) analysis in...
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...
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.
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...
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...
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...
