H1ST-AI-PM-007
An SAE mismatch shouldn't become a reporting failure
The mismatch you want to catch is the one that would otherwise become a reporting failure, and you want to catch it early. The agent tracks serious adverse events and SUSARs across the study and continuously reconciles the EDC against the safety database, catching mismatches in terms, dates, seriousness, and causality and flagging discrepancies and unreported cases for safety and operations to resolve. Reconciliation that once meant manual line-listings becomes an automated, always-current control.
The grind you know
Your SAE data lives in two places, the EDC and the safety database, and reconciling them by hand is tedious work where a single slip carries real weight. A mismatch in seriousness, causality, or an onset date gets through, and suddenly you're facing late or inaccurate expedited reporting. Across all your sites, you have no real-time view of where reconciliation actually stands.
Part of the Clinical Project Management family
Action items, status, deviations & comms.
The mismatch you want to catch is the one that would otherwise become a reporting failure, and you want to catch it early. The agent tracks serious adverse events and SUSARs across the study and continuously reconciles the EDC against the safety database, catching mismatches in terms, dates, seriousness, and causality and flagging discrepancies and unreported cases for safety and operations to resolve. Reconciliation that once meant manual line-listings becomes an automated, always-current control.
The agent ingests SAE data from the EDC and case records from the safety database.
It compares matched cases field by field and identifies discrepancies and cases present in only one system.
Flagged items are routed to safety and operations for correction, with reconciliation status tracked to closure.
Capabilities
Maintain a live register of serious adverse events and SUSARs with status, seriousness, and reporting timelines.
Automatically compare EDC and safety-database records to detect field-level discrepancies and missing cases.
Mismatches in terms, dates, seriousness, or causality are surfaced with severity for prompt resolution.
Track expedited-reporting clocks so SUSARs are actioned within required timelines.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
An SAE is recorded with different seriousness in the EDC than in the safety database. Field-level reconciliation flags the discrepancy before it becomes an inaccurate expedited report.
An event was entered in the EDC but never reached the safety database. The agent flags the unreported case so it's resolved before a reporting deadline lapses.
A SUSAR's expedited-reporting window is closing. The timeline watch tracks the clock against required timelines so safety staff action it in time, while the medical assessment stays with qualified reviewers.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Medidata Rave
EDC
IWRS / RTSM
IWRS/RTSM
Who it's for
Protocol-deviation tracking and categorization with integrated CAPA management aligned to ICH E6.
Learn moreAutomated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
Learn moreA consented, compliant-channel WhatsApp workflow for physician and site-team notifications, response capture, and AI-driven next steps.
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.
