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Stop rebuilding the TMF before every audit.

SmartTMF is AI-powered trial master file software that classifies, files and checks documents as the trial happens — so inspection readiness is a daily state, not a quarterly project.

Everything a TMF team does — minus the drudgery

AI auto-classification

Every incoming document mapped to the TMF Reference Model with a confidence score — your team confirms with one click.

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Missing-document detection

SmartTMF knows what a complete TMF looks like for your study design and flags gaps before an inspector does.

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Inspection-readiness score

A live score per study, country and site — the number your sponsor asks for, always current.

Duplicate & version control

Superseded versions, scanned duplicates and mis-filed copies caught automatically.

Human-in-the-loop QC

AI suggests; named people approve. Every decision is attributable, contemporaneous and audit-trailed.

Chase lists that act

Missing docs become assigned chase tasks with owners and due dates — not a spreadsheet nobody opens.

Cuts the manual filing burden Gaps surfaced earlier, not at audit Inspection-ready as you go
Built for GCP from day one
21 CFR Part 11 TMF Reference Model ICH-GCP E6(R3) Full audit trail
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Book a discovery call

See SmartTMF on one of your studies

20 minutes. We load a real study structure and show the AI filing live — then you decide.

20 minutes, no deck — we show the product live
Bring one of your own studies if you like
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