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elsai Clinical Protocol Audit Agent

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elsai Clinical Protocol Audit Agent helps sponsors, CROs, regulatory affairs teams, compliance specialists, and medical writers review clinical study documents with greater consistency, traceability, and control. The agent evaluates protocols, informed consent forms, recruitment materials, and other clinical study documents against configurable validation and compliance rules. Instead of returning unsupported findings, every issue must be backed by exact source text from the document. If supporting evidence cannot be verified, the finding is excluded. For each validation rule, the agent identifies the relevant section, verifies the underlying evidence, determines whether the document meets the requirement, explains the reasoning, and provides a confidence score. Where appropriate, it can also recommend corrected or replacement text for human review.

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