Agentic AI for clinical operations that QA will sign off onagentic AI
Trials run on documentation, not just data. We deploy agents that activate sites, chase queries, and draft safety narratives inside your validated systems — every action attributable, time-stamped, and audit-ready.
- GCP & 21 CFR Part 11 by design
- Inside your VPC — PHI never leaves
- Validated EDC/CTMS/eTMF integrations
- Human sign-off on every regulated record
The bottleneck isn't the science. It's the paperwork around it.
A modern Phase III runs across dozens of sites, three EDCs, an eTMF, a CTMS, and a safety database that rarely agree with each other.
Coordinators spend their days reconciling case report forms against source documents, chasing investigators for overdue queries, and re-keying the same enrollment numbers into four systems. None of that work moves the science forward — but a missed query or a stale TMF document is exactly what a sponsor audit or an FDA inspection flags first.
The instinct is to throw more CRAs and data managers at the problem. The cost scales linearly and the timelines don't improve. The real leverage is in the structured, rule-bound, endlessly repetitive handoffs between systems — precisely the work an agent does well, provided it operates under GCP discipline and leaves a trail QA can defend.
Where agents earn their keep in the clinic
Narrow, high-frequency workflows with clear rules and clear owners — automated end to end, with a human on the regulated steps.
Site activation
Agents assemble the regulatory binder, track IRB/EC submissions, and flag missing 1572s and CVs so sites go live in weeks, not months.
Query management
Reconcile CRF data against source, auto-draft and route queries to the right site, and escalate aging items before they age out.
eTMF completeness
Continuously scan the trial master file for missing, expired, or misfiled documents and surface gaps before an inspection does.
Safety & pharmacovigilance
Triage incoming AE/SAE reports, draft narratives from source, and pre-fill MedWatch and E2B for a safety physician's sign-off.
Enrollment monitoring
Track screening, randomization, and dropout across sites in real time and forecast which sites will miss recruitment targets.
Cross-system reconciliation
Keep EDC, CTMS, IRT, and the safety database in sync without coordinators re-keying the same numbers four times.
How we deploy without breaking validation
Compliance is the design constraint from the first call — not a clean-up step at the end.
Map & risk-rate
We map your study workflows and risk-rate each one, separating GxP-critical steps from the manual glue we can automate first.
Validate
We build under GAMP 5, generate IQ/OQ/PQ artifacts, and define the human approval gates your SOPs require.
Deploy in-perimeter
Agents run inside your validated VPC or on-prem, integrated to your EDC, CTMS, and eTMF via change-controlled connectors.
Monitor & extend
We track query cycle time, TMF completeness, and exception rates, then expand to the next workflow as trust compounds.
Built for the inspection you haven't scheduled yet
Every agent decision is recorded in an ALCOA+ audit trail — attributable to the agent and its supervising human, contemporaneous, original, accurate, and complete. There's no black box: you can replay why an agent drafted a given query or flagged a given document, down to the source record it cited.
High-stakes actions never auto-complete. Closing a query, finalizing a safety narrative, or marking a TMF document final requires an electronic signature from the qualified human who owns that step. The agent does the assembly; your team retains the judgment and the accountability.
- ALCOA+ audit trails on every action
- 21 CFR Part 11 electronic signatures
- GAMP 5 validation deliverables (IQ/OQ/PQ)
- Role-based access and full decision lineage
Manual CRO workflow vs. an Automatic.co agent
Same regulatory bar. A fraction of the cycle time.
| The manual way | An Automatic.co agent | |
|---|---|---|
| Query turnaround | Days of back-and-forth email | Drafted and routed in minutes, human-approved |
| TMF gaps | Found during pre-inspection scramble | Surfaced continuously, in real time |
| Reconciliation | Coordinators re-key across systems | Synced automatically across EDC/CTMS/safety |
| Audit trail | Reconstructed after the fact | ALCOA+, captured as the work happens |
| Scaling a study | Hire more CRAs and data managers | Add sites without adding headcount |
Frequently asked questions
Are these agents 21 CFR Part 11 and GxP compliant?
They're built for it. Every agent action is captured in an attributable, contemporaneous, time-stamped audit trail, validation artifacts are generated as part of the build, and electronic signatures gate any record a human must approve. We deliver the IQ/OQ/PQ package your QA team needs to sign off.
Will agents make clinical decisions or alter source data?
No. Agents draft, reconcile, flag, and route — they never overwrite source data or render medical judgment. A coordinator, monitor, data manager, or safety physician approves anything that touches a regulated record, and that approval is logged with the underlying reasoning.
How do you handle PHI and patient privacy?
We deploy inside your validated environment — your VPC or on-prem — so PHI and source documents never leave your perimeter. Agents run under HIPAA-aligned controls with role-based access, de-identification where required, and BAAs in place before a single record is touched.
How does this fit our existing EDC, CTMS, and eTMF?
Agents work through your existing stack — Medidata Rave, Veeva Vault, Oracle, IQVIA, or a custom EDC — via validated integrations. We don't ask you to rip and replace; we automate the manual reconciliation and handoffs between systems you already run.
Related industries & capabilities
Automation that travels well across regulated, document-heavy operations.
Bring one study workflow. Leave with a validated plan.
A single working session to map your highest-friction clinical ops workflow and the compliant path to automating it.