Clinical Trial Document and Deviation Agent
Sponsors and contract research organisations running trials across more than ten sites
Clinical ResearchAdvanced8.38-12 weeks to MVP
Problem
A trial master file is inspected on completeness and assembled from documents emailed by sites in inconsistent formats. Protocol deviations surface at monitoring visits weeks after they happened, by which point the same deviation has occurred nine more times at the same site.
Solution
An agent that checks each incoming document against the expected artefact list for that site and visit, reads source data for deviations against protocol-derived rules, and flags reportable ones with the deadline attached.
Tech stack
Next.jsClaudePostgreSQLeTMF APIEDC APIDocument storage
Required integrations
- eTMF system
- EDC or clinical database
- CTMS for site and visit schedules
- Document intake from sites
Key features
- Expected-artefact checking per site, visit, and country
- Deviation detection against protocol-derived rules
- Reportability assessment with the deadline stated
- Site completeness view ahead of monitoring visits
- Cross-site trending on the same deviation
ClinicalDocumentsComplianceDeadlines
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Guides for this build
Read these alongside the spec.