TMF360 unifies document management, gap detection, and inspection readiness into a single real-time view — so your team always knows what's complete, what's missing, and what needs attention next.
Your AI TMF assistant understands your trial, your documents, and your workflows.
Site 102 is missing 12 essential documents. 2 documents are overdue. Inspection readiness risk is Medium.
Book a Demo →AI understands your TMF context, not just keywords.
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AI helps you stay inspection-ready at all times.
Improves with every interaction across your studies.
Six things TMF360 does for your team, all live in the platform today.
Set your study's milestones and TMF360 builds the expected-document list from the TMF Reference Model. Completeness is filed against expected, so gaps show up before an inspector finds them.
Every upload lands in Document Intake first. It's re-hashed, checked for duplicates and missing fields, then reviewed in QC by a person who signs the decision.
A rules engine scores TMF health and ranks every finding by risk, with the reasons behind it. Studies are re-checked as documents change and snapshotted daily.
Give an inspector a time-limited link and access code. They see only the documents in scope, read-only, and every view is logged.
AI proposes where a document belongs and flags issues before QC. Each suggestion is stored with what the reviewer chose, and AI can be switched off for your organisation.
A hash-chained audit trail, e-signatures with a password re-check, and server-set timestamps. Deletes are soft, with a 180-day restore, so nothing is ever hard-deleted.
Portfolio-level oversight across all studies.
Multi-study management with complete visibility.
Complete TMF control and document integrity.
Site visit preparation and document access.
Efficient document filing and quality submissions.
Structured QC workflows and compliance checks.
Real-time study status and performance insights.
Submission-ready packages and regulatory alignment.
Easy document submission and site collaboration.
Read-only audit access with full traceability.
Move beyond passive document storage. TMF360 gives your team the visibility, control, and AI-powered insight to stay inspection-ready at every stage of your trial.