H1ST-AI-PM-007
A stalled CAPA shouldn't surface at inspection
When the inspector traces a deviation, you want the root cause, the CAPA, and the proof it worked all sitting right there. The agent logs protocol deviations, categorizes them by severity and type, and drives the corrective and preventive action lifecycle to closure, linking each deviation to root cause, CAPA, effectiveness check, and the affected sites or subjects, consistent with ICH E6(R3) quality expectations. Sponsors and QA get a defensible, trend-aware record instead of scattered spreadsheets.
The grind you know
When your deviations are scattered across disconnected logs with inconsistent categorization, the trends and recurring root causes that would tell you something stay hidden. CAPAs stall out without clear ownership or an effectiveness check, and that gap between a deviation and its remediation is precisely what an inspector finds. Reconciling it all across sites by hand is slow, and it's never quite complete.
Part of the Clinical Project Management family
Action items, status, deviations & comms.
When the inspector traces a deviation, you want the root cause, the CAPA, and the proof it worked all sitting right there. The agent logs protocol deviations, categorizes them by severity and type, and drives the corrective and preventive action lifecycle to closure, linking each deviation to root cause, CAPA, effectiveness check, and the affected sites or subjects, consistent with ICH E6(R3) quality expectations. Sponsors and QA get a defensible, trend-aware record instead of scattered spreadsheets.
Deviations are logged with structured category, severity, and affected subjects or sites.
The agent trends deviations by root cause and site to surface systemic risks.
CAPAs are assigned, tracked, and verified for effectiveness until formally closed.
Capabilities
Capture deviations with consistent severity and type classification, including important vs minor distinctions.
Group deviations by root cause and site to reveal systemic issues and recurring patterns.
Assign corrective and preventive actions with owners, due dates, and effectiveness checks through to closure.
Workflows reflect ICH E6(R3) quality-management and issue-escalation expectations.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
An inspector picks an important deviation and asks for the full story. The linked record shows root cause, the CAPA, its owner, and the effectiveness check that confirmed it worked, consistent with ICH E6(R3), instead of scattered spreadsheets.
The same consent-process error appears across three sites. Root-cause and site trending groups the related deviations, revealing the systemic pattern that individual logs would have hidden.
A corrective action drifts without closure. The CAPA lifecycle enforces an owner, due date, and effectiveness check, so the gap between a deviation and its remediation doesn't surface at inspection.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Medidata Rave
EDC
Veeva Vault
EDC
Who it's for
SAE and SUSAR tracking with automated reconciliation between the EDC and the safety database.
Learn moreAutomated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
Learn moreAn AI agent that reads project email and meeting notes to extract action items, assign owners, and track them to closure.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
