An inspector reads the trial master file to reconstruct how the trial was run. Gaps found the week before an inspection are expensive; gaps found the day after filing are a five-minute fix.
AI trial master file quality control reads every document as it is filed in the eTMF, checks it against the TMF Reference Model and your study’s expected-document list, and raises problems for the TMF owner to resolve: wrong artefact type, wrong site or country, missing signature or date, an expired version, a document that should exist and does not. It runs continuously, so the file is inspection-ready as a matter of routine.
It integrates with the eTMF you use, such as Veeva Vault eTMF or a comparable system, through its API. It never refiles, signs or deletes a document on its own; under ICH E6(R3) and EMA guidance on the TMF, the sponsor and investigator remain responsible for its completeness, and the audit trail has to show that people made each change.
new or updated document
text, layout, signatures, dates
against the TMF Reference Model
metadata, completeness, quality rules
logged with the checks it passed
reason and evidence attached
It is the routine check that the trial master file is complete, accurate and filed correctly, so it can reconstruct how the trial was conducted. Traditionally it is done by sampling documents by hand before key milestones. AI makes it possible to check every document at filing, so sampling becomes a check on the checker rather than the main control.
Yes. Classifying documents against the TMF Reference Model is a well-defined task for current document models, and accuracy can be measured on your own filed documents before relying on it. We set the system to raise uncertain cases for a person rather than guess, which keeps misfiling from slipping through silently.
If it influences the content or management of GCP records, it should be validated proportionately to that risk, and its own actions need an audit trail. We design it to be validatable: versioned models, fixed test sets and full logging. The validation plan and the decision on its scope are your quality function’s.
What we built, what stage it is at, and a link to the live thing wherever there is one.
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Start with an export of one study’s eTMF and we will show what continuous QC would have raised.
30-minute technical call · no deck