Upload a clinical protocol. Get a complete Risk-Based Quality Management framework with CTQFs, QTLs, and a risk register — fully traceable, fully yours to review.
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AI extracts CTQFs directly from your protocol text — not generic templates. Blinding integrity, dosing algorithms, safety thresholds.
Measurable thresholds for each CTQF. Amber warnings trigger enhanced monitoring; red alerts trigger CAPA — all adjustable in real time.
Likelihood, impact, control actions — every risk linked back to its parent CTQF and QTL. Top priorities surfaced automatically.