Beyond the EHR: meeting the FDA’s new real-world evidence standards
The FDA’s December 2025 device guidance and March 2026 ICH M14 adoption raise the bar for RWE programs. Here is what changed.
Early-stage biotech’s AI advantage is a window that closes. Sol Babani and Derk Arts on how to use it.
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.
Joel White’s Q4 CRO breakdown: strong bookings, a sell-off that didn’t match, and the disruption gap nobody is talking about
Q4 CRO revenues grew. Bookings accelerated. So why the AI panic? Joel White breaks down what the numbers actually mean.
What AI replaces in Phase 2/3 data management, and the edit check question your team hasn’t asked yet
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 and real-world evidence: not a spectrum, a strategic choice
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 here: what your centralized monitoring strategy needs right now
ICH E6(R3) is in effect. Castor’s recap covers centralized monitoring, sponsor accountability, and closing the biotech RBQM gap.
On-site ePRO in Action: A Recap of Castor’s Product Spotlight
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.
EQ-5D in European Trials: When Generic QoL Measures Actually Matter
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.
ePRO, eCOA 101: Everything You Need to Know About ePRO and eCOA
Electronic Clinical Outcome Assessment (ECOA) and electronic Patient Reported Outcomes (ePRO) represent far more than digital surveys in clinical trials. This foundational guide explains the four ECOA components (ePRO, eClinRO, eObsRO, ePerfO), why BYOD delivers superior patient compliance over provisioned devices, and the hidden complexities of copyrighted instruments approval. Discover why commercial trials demand specialized expertise in linguistic validation, regulatory compliance, and measurement equivalence that academic research often overlooks. Essential knowledge for clinical operations professionals planning their next patient outcome strategy.
