AI-Powered · ICH E6(R3) · ICH E8(R1)

Your RBQM framework — in minutes, not weeks

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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HOW IT WORKS
Three phases, complete traceability

01 — Critical-to-Quality Factors

AI extracts CTQFs directly from your protocol text — not generic templates. Blinding integrity, dosing algorithms, safety thresholds.

02 — Quality Tolerance Limits

Measurable thresholds for each CTQF. Amber warnings trigger enhanced monitoring; red alerts trigger CAPA — all adjustable in real time.

03 — Risk Register

Likelihood, impact, control actions — every risk linked back to its parent CTQF and QTL. Top priorities surfaced automatically.

ICH E6(R3) ICH E8(R1) Human-in-the-loop Full PII anonymisation Audit trail No infrastructure changes