Documents, Operations & Support · H1ST-AI-DOC-006
An eTMF that files and manages itself.
The problem this family owns
This is the stretch of the trial where the work is repetitive, deadline-bound, and unforgiving of small errors — the part a stretched team feels first, and the part where a missed detail is most expensive to fix later.
The eTMF & Documents family puts a purpose-built agent on each of these. You stay in control of every output — the agents absorb the grind, not the judgment.
Where it fits
An inspection-ready electronic Trial Master File built on the TMF Reference Model v3.3.1 (250 artifacts across 11 zones). eTMF & Documents classifies, auto-files, routes, e-signs, and version-controls every essential document.
It sits in the Documents, Operations & Support suite — a compliant etmf and an ai project team — and is delivered as 5 individually-deployable AI agents you can adopt one at a time or as a complete workflow.
The agents
Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.
A BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreAn AI classifier that reads clinical documents and assigns the correct TMF zone, section, and artifact with extracted metadata.
Learn moreAn intelligent dump-folder that auto-assigns metadata and files documents to the correct TMF location behind a review-and-approve gate.
Learn moreA review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
Learn moreDocument version control with change tracking, side-by-side comparison, and controlled archive management for the TMF.
Learn moreOne workflow, not point tools
Enabled together, the eTMF & Documents agents hand off in sequence — each one's output becomes the next one's input, so nothing is re-keyed and nothing falls between the seams.
A BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
An AI classifier that reads clinical documents and assigns the correct TMF zone, section, and artifact with extracted metadata.
An intelligent dump-folder that auto-assigns metadata and files documents to the correct TMF location behind a review-and-approve gate.
A review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
Document version control with change tracking, side-by-side comparison, and controlled archive management for the TMF.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Straight answers
Pulled from the questions teams ask most about the agents in this family — answered plainly, including where the honest answer is a limit.
No pitch, no pressure — a working walkthrough on your own workflow and honest answers, including on the limits. Bring the study that worries you most.
