H1ST-AI-DOC-006 · AI Common Features
Fast filing shouldn't mean a mass-upload red flag
You get the speed of a dump folder without the red flag that comes with one. Users drop documents into a single inbox and the agent proposes the TMF destination, metadata, and naming, then holds each filing decision for reviewer approval before commit. That deliberate approval gate removes the manual filing effort while leaving a clear human decision on record for every artifact, fast, defensible filing you can stand behind.
The grind you know
You are caught between two bad options: bulk uploads and shared-drive dumps that inspectors distrust because no one can show a per-document filing decision, or manual filing that becomes the bottleneck delaying your TMF completeness. What you actually need is speed that doesn't cost you the auditable, reviewed placement of every single document.
Part of the eTMF & Documents family
An eTMF that files and manages itself.
You get the speed of a dump folder without the red flag that comes with one. Users drop documents into a single inbox and the agent proposes the TMF destination, metadata, and naming, then holds each filing decision for reviewer approval before commit. That deliberate approval gate removes the manual filing effort while leaving a clear human decision on record for every artifact, fast, defensible filing you can stand behind.
Contributors place documents in the dump inbox with no need to choose a TMF location.
The agent classifies each item and generates a filing proposal with metadata, destination, and confidence.
A reviewer confirms or adjusts each proposal, and only approved items are committed to the TMF with an audit entry.
Capabilities
Contributors drop any document into one folder and the agent handles routing, so users need no knowledge of TMF structure.
The agent predicts TMF location, metadata, and standardized file name for each document, ready for confirmation.
Every proposed filing is queued for reviewer approval, creating a per-document decision record rather than a mass upload.
Reviewers accept, correct, or reject proposals in bulk while each individual decision is logged separately.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
You have hundreds of documents to file and no time for manual placement. Contributors drop them in one inbox and the agent proposes destination, metadata, and naming, but each filing waits for reviewer approval, so you get speed and a per-document decision record inspectors trust.
A reviewer clears a queue of 80 proposals in one sitting. The console supports batch accept and correction, yet logs each approval separately so the audit trail stays granular.
The agent mis-proposes a destination for an unusual artifact. The reviewer rejects it with a note, the item returns to the queue for reclassification, and the rejection itself is logged for traceability.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Paddle OCR
OCR
Gemini / Anthropic LLM
LLM
Veeva Vault
EDC
Who it's for
An AI classifier that reads clinical documents and assigns the correct TMF zone, section, and artifact with extracted metadata.
Learn moreA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreA review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
