Continuously reconcile trial master file contents against the expected-document list per site and study, auto-drafting document requests for gaps and producing an inspection-readiness score, so you are never caught with a missing document.
Missing or expired documents from sites and CROs need to be chased down constantly, and reconciling document status against the reference checklist is a recurring, high-volume task.
Completeness gaps that go unnoticed are a leading driver of inspection findings.
against the expected-document list per site and study
Completeness and quality judgment
The TMF reconciliation for Site 014 of the CM-2201 study surfaced an expired 1572 form and a missing monitoring visit log, dropping the site's inspection-readiness score below the internal threshold. A document-request draft is ready for the TMF specialist to confirm.
Try it — same review surface your operators use, with a representative decision. Nothing here is saved or sent anywhere.
The final completeness and quality judgment call ahead of an inspection stays with your TMF specialists and clinical operations team.
See this workflow against your own queue.
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