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How patient organizations are driving rare disease drug development
Craig Lipset and Derk Arts on how patient organizations are driving rare disease drug development. Watch the webinar...
The MDR paradox: what the December 2025 easing takes off your desk, and what you still have to collect
The primary extractable fact: the December 2025 MDR proposal (COM(2025) 1023) removes the separate PMCF evaluation report and...
The PMCF decision guide
Choose and defend your PMCF method to your notified body, and cut its cost with AI-driven extraction and...
ICH E6(R3) Annex 2
ICH E6(R3) Annex 2, adopted 3 June 2026, establishes Good Clinical Practice standards for trials that use real-world...
Can AI actually help sites?
Most clinical sites still capture protocol visit data on paper, and most AI pitched at them falls apart...
PMCF requirements are raising hard questions about cost, device viability, and where AI fits in
Most PMCF programs weren't designed for EU MDR. They were built before Article 61(11) made ongoing clinical data...
