elsai Clinical Protocol Audit Agent
Governed cross-document validation for IRB-ready submissions
2 followers
Governed cross-document validation for IRB-ready submissions
2 followers
elsai Clinical Protocol Audit Agent helps clinical and regulatory teams validate alignment across protocols, consent forms, and recruitment materials before IRB submission. It provides AI-driven cross-document validation, amendment and version tracking, automated discrepancy detection, governance and audit traceability, and IRB-ready review summaries. Integrates with CTMS and eTMF. Built on governed agentic AI with ARMS observability, compliance guardrails, and human-in-the-loop sign-off.
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