Risk-based monitoring finds critical data errors after the fact — at the next on-site visit, weeks after entry, when the deviation and the CAPA are already inevitable.

This animation follows one example end to end. A site coordinator logs a prohibited concomitant medication under a regional brand name. In the legacy process, it sits in the EDC unflagged until a monitor finds it — a major protocol deviation, a CAPA workflow, and possible data exclusion.

In the modern process, an agentic validation layer works at the moment of entry: it resolves the brand name to its active ingredient (ATC code), reasons over the protocol's Critical-to-Quality (CTQ) constraints, and fires a soft query before the dose is ever administered — pause study drug dispensing, contact the Medical Monitor.

The second half shows how those checks are provisioned. CoReason drafts candidate CTQ factors across CTTI's six categories from your protocol, SAP, and SOPs; your cross-functional team ranks and signs them into the CTQ Registry. Text is extracted, normalized, and cross-referenced against MedDRA and clinical dictionaries, and every finding is gated through the registry: does it touch an error that matters? The output is structured JSON specs linked to their source sections, a CDISC ODM / ALS study build, human review, and programmatically provisioned eCRF forms, fields, and edit checks.

Every check traces back to the section that demanded it. Reasoning you can audit.

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