🧪 AI autopilot · cro

Clinical-trial-ops autopilot

Screens patients and runs monitoring — the PI / medical monitor signs eligibility and safety calls.

Sponsor / CRO operations leadbuys it $20–28B USmarket 5 auto · 1 humanflow steps

The problem

Trial operations — eligibility screening, source-data verification, reg-doc assembly — are slow, manual and Part 11 / GCP-validated, gating the cost and speed of every study.

What you get

Patients are screened and matched, data abstracted and deviations flagged, and reg packages assembled straight-through; the PI / medical monitor signs eligibility and safety decisions.

The flow

Intake to outcome. 🤖 steps run automatically; 🧑‍⚖️ steps are where a named human signs off the judgment calls.

  1. 1
    🤖 Ingest the protocol and patient records from the EHR
    agent intake · Clinical trial mgmtEHR (FHIR)
  2. 2
    🤖 Screen and match eligible patients and abstract source data
    agent screen · Trial eligibility matchingElectronic data capture
  3. 3
    🤖 Flag protocol deviations and assemble the monitoring / regulatory package
    agent compliance · Electronic data captureRegulatory docs / eTMF
  4. 4
    🧑‍⚖️ The PI / medical monitor signs eligibility and any safety determination Human checkpoint
    Principal investigator / medical monitor
  5. 5
    🤖 Enroll the patient and submit the regulatory documents (Part 11) ⚠ Irreversible · high blast
    agent execute · Regulatory docs / eTMF
  6. 6
    🤖 Monitor safety signals and maintain the eTMF
    agent monitor · Clinical trial mgmt

Agents & tools

  • Clinical trial mgmt stub → Veeva CTMS
  • EHR (FHIR) ● live · Epic
  • Trial eligibility matching stub → Triomics
  • Electronic data capture stub → Medidata Rave
  • Regulatory docs / eTMF stub → Veeva Vault

1 of these run live on real data — keyless by default; the rest are sandbox stubs that flip to the real provider the moment you add credentials.

Human checkpoints

  • Principal investigator / medical monitor — The PI / medical monitor signs eligibility and any safety determination

The autopilot escalates the judgment calls to a qualified human — the rest is straight-through.

Why it's safe to let it run

Every autonomous decision is logged — who · what · confidence. Signed human checkpoints and a built-in compliance reviewer enforce the rails, so the outcome holds up to an audit, not just a demo. Every irreversible action runs only after a human signs — the autopilot does the volume, never the point of no return on its own.

🧑 Accountable owner: Principal investigator / medical monitor — one person answers for what this autopilot does.

Related autopilots

Same buyer, adjacent function — the connectors and compliance packs are shared.

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