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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...
