Drug safety, governed by the clock.
Every adverse-event report becomes a long-running case that carries its own regulatory deadline, escalates the moment a patient turns serious, and refuses to close without a physician's sign-off.
When a patient is harmed, a legal clock starts. VIGIL makes that deadline a property of the case — not a reminder someone has to remember.
One report, five governed stages
Each adverse-event report flows through a stage-based case, with agents doing the work and a physician accountable for the serious call.
Intake
Extracts the four ICH E2B core elements from the raw report and validates completeness.
Triage
Assesses seriousness against ICH criteria and assigns the 7- or 15-day reporting deadline.
Medical Review
A physician records the decision — approve, request information, or reject. The case cannot pass without it.
Reporting
Generates the ICH E2B submission summary and identifies the regulators to notify — FDA, EMA, and beyond.
Closure
Verifies completion, produces the full audit record, and closes the case for inspection.
Expedited Escalation
When a case turns serious, an interrupting exception path pulls it out of the normal flow onto the urgent track.
A missed deadline is a reportable failure.
Pharmacovigilance is a legal obligation for every pharmaceutical company on earth. Serious adverse events must be assessed, signed off, and filed within a fixed window — as little as seven days.
- The deadline rides on the case from intake to closure, warning before it breaches.
- Reclassification to serious triggers an immediate, interrupting escalation.
- Every transition is recorded — an audit trail ready for inspection.
Two features that carry the weight
The regulatory SLA clock
A 15-day case-wide deadline that warns the team at 80% — with roughly three days of runway — and escalates the instant it breaches.
The interrupting exception
A secondary stage that fires the moment a case is flagged serious, interrupting active work and routing it to the expedited path.
A coding agent built the brain that drives the routing.
The causality service is coded Python — built through a coding agent connected to UiPath's official integration — that computes WHO-UMC causality and outputs the seriousness value the Maestro case uses to escalate.
- WHO-UMC causality across six categories, deterministic and testable.
- ICH E2D seriousness and the binding 7 / 15 / 90-day deadline.
- Ten of ten self-tests passing — verifiable from the source alone.