Expert insights on PRO data, regulatory uncertainty, and the implementation gap that kills most ePRO strategies. Watch the on-demand recording.
The FDA’s December 2025 device guidance and March 2026 ICH M14 adoption raise the bar for RWE programs. Here is what changed.
Sol Babani and Derk Arts on why early-stage biotech must build AI-native operations, not retrofit old ones. Decision frameworks and key caution inside.
Q4 CRO revenues grew. Bookings accelerated. So why the AI panic? Joel White breaks down what the numbers actually mean.
Alison Bishop and Derk Arts on what AI actually replaces in Phase 2/3 data management, with a deep dive on the future of edit checks.
Phase 4 is a post-approval interventional trial that fulfills regulatory commitments. Real-world evidence spans PASS, PAES, HEOR, natural history studies, and more — each built to answer a different question for a different stakeholder. This piece maps the full range of post-approval study types, where Phase 4 and RWE genuinely converge, and how to treat both as part of a coordinated evidence strategy.
ICH E6(R3) is in effect. Castor’s recap covers centralized monitoring, sponsor accountability, and closing the biotech RBQM gap.
Castor’s on-site ePRO adds in-clinic PRO capture to the ePRO/CDMS workflow you already use. Staff use a site device or share a QR code for BYOD. Progress saves automatically during completion, and participants can finish remotely. It reduces missed baseline at FPI. It supports decentralized and hybrid designs. It improves audit readiness and compliance tracking. No separate site app or provisioned hardware. This article recaps the webinar, shows the clinic flow, and answers common questions.
Analysis of 735 FDA drug approvals reveals 0% EQ-5D labeling inclusion, while European HTA bodies demonstrate 18% technology appraisal acceptance. Companies repositioning EQ-5D from FDA regulatory strategy to European HTA advantage secure faster reimbursement approvals. German HTA bodies show highest global acceptance rates, NICE maintains established preference despite 5L controversies, and French HAS recognizes EQ-5D within economic evaluation frameworks. Strategic implementation focuses on health economic modeling rather than clinical outcome measurement, with HTA-optimized deployment (12-16 weeks) providing superior ROI versus regulatory claim attempts. Success requires country-specific value sets and preference weights.
