H1ST-AI-MON-003 · Task 2.3
Risk accumulates between your monitoring visits
When oversight only happens at visits, the risks that build in between are the ones that hurt — and ICH E6(R3) now expects you to catch them centrally. The KRI / Central Monitoring Agent lets you configure monitoring rules and quality tolerance limits — temperature thresholds, lab ranges, protocol deviations — computes Key Risk Indicators across all sites, and presents findings on a severity-classified dashboard, so your oversight is continuous rather than visit-driven and on-site effort goes where the data says it's needed.
The grind you know
Between monitoring visits, risk quietly accumulates and you can't see it — traditional oversight is periodic and site-by-site, so comparing one site against another means waiting for the next visit and piecing it together by hand. Without configurable KRIs and tolerance limits, you're left guessing whether a wobble is normal variation or a site drifting toward a real quality problem, and the answer usually arrives too late to be cheap.
Part of the Risk-Based Monitoring family
Risk-based monitoring & safety oversight.
When oversight only happens at visits, the risks that build in between are the ones that hurt — and ICH E6(R3) now expects you to catch them centrally. The KRI / Central Monitoring Agent lets you configure monitoring rules and quality tolerance limits — temperature thresholds, lab ranges, protocol deviations — computes Key Risk Indicators across all sites, and presents findings on a severity-classified dashboard, so your oversight is continuous rather than visit-driven and on-site effort goes where the data says it's needed.
Set monitoring rules, KRIs, and quality tolerance limits that reflect the protocol's risk profile — no coding required.
The agent computes KRIs across all sites and evaluates each against its tolerance limits as data arrives.
Findings appear on a severity-classified dashboard with site risk ranking, directing central and on-site monitoring effort.
Capabilities
Define rules on any monitored value — temperature thresholds, lab ranges, enrollment or deviation patterns — without code, so oversight matches the protocol's risk profile.
Computes KRIs across sites and evaluates them against quality tolerance limits, distinguishing expected variation from signals that breach acceptable limits.
Presents findings on a dashboard that ranks each by severity, giving the central monitoring team a prioritized, study-wide view of risk.
Aligns to ICH E6(R3) risk-based monitoring, aggregating signals centrally so on-site effort is directed where the data shows it's needed.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
Between site visits, risk accumulates where periodic, site-by-site oversight can't see it. The agent computes Key Risk Indicators across all sites as data arrives, so your oversight is continuous rather than waiting for the next visit.
A wobble in a site's data could be normal variation or the start of a real quality problem, and guessing is expensive. KRIs evaluated against quality tolerance limits distinguish expected variation from a genuine breach, so you know when to act.
You have limited on-site days and want them spent where they matter. The severity-classified dashboard and site risk ranking direct monitoring effort to the sites and issues the data flags, rather than a fixed schedule.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Medidata Rave
EDC
Oracle Clinical
EDC
IWRS / RTSM
IWRS/RTSM
Who it's for
Reads source documents with OCR and clinical NLP to surface review findings, each with a confidence score.
Learn moreAggregates events across sites to detect safety signals and suggests medical coding for faster review.
Learn moreRuns the full query lifecycle — auto-populating responses, tracking status, and escalating by age, type, and priority.
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.
