eTMF agent

Documents organized. Audits cleared.

Medable’s eTMF agents take on the high-volume work of organizing and filing trial documents, operating continuously across studies so teams can move from manual execution to oversight.

Automation without the blind spots

Automate document intake from inbox to eTMF, with intelligent classification, metadata extraction, and compliant filing—backed by confidence scoring and multilingual support for global scale.

Complete oversight

Agents handle the volume; your team reviews, approves, and stays in control where it matters.

Audit-ready by design

Every action is tracked with clear traceability, so documentation is inspection-ready without extra effort.

Fits with your TMF

Agentify your current TMF by automating how documents are organized, reviewed, and submitted.

Every file has to be checked, renamed, tagged, and uploaded by hand. It’s incredibly time-consuming, and even with good people, things get missed.
TMF Operations Lead, Top 10 Pharma

Focus on progress, not paperwork.

  • 60% time saved per TMF document for classification
  • Continuous document intake and organization
  • Fewer backlogs and last-minute scrambles
  • Designed to comply with all global regulations, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR

TMF Automation in Action

Frequently asked questions

How are agent recommendations ensured to be trustworthy and free from data quality issues?

Agents operate in a controlled environment with rigorous validation checkpoints, business logic guardrails, and real-time monitoring. Every agent is subject to verification workflows and data quality checks before being surfaced to users, ensuring accuracy, compliance, and auditability. Medable recommends human remain involved whenever the task carries higher risk.

Where is the audit trail stored?

All actions, prompts, responses, and connector events are logged within the platform. Once documents are filed in the target TMF system, that system’s native audit trail records the final action as well.

How accurate is the document classification?

Each classification includes a confidence score. Users decide when to accept or adjust results.