Capture & triage
Bring intake from emails, PDFs, forms, literature, and service partners into a governed review queue.
Intelligent safety. Global trust.
Intelligent safety.
Global trust.
Vigilytics is the AI-first pharmacovigilance workspace for teams that need to move safety cases forward with speed, evidence, and accountable expert review.
Human oversightTraceable workflowsGlobal readiness
workspace.vigilytics
AI Co-Pilot
Review-readyTriage this intake and prepare a review checklist…
Case intake•Priority review
Intake
Coding
Literature
Signals
Safety workspace
Evidence remains connected to each action.
The safety operating system
From first signal to defensible action.
One connected workspace for ICSR operations, regulatory work, safety intelligence, and quality teams.
AI-assisted intake classification and prioritization
Auditable case processing and coding workflows
E2B(R3) readiness and submission tracking
Signal, literature, and aggregate reporting workspaces
Role-aware quality controls and inspection evidence
Process with evidence
Support case processing, coding, follow-up, duplicate review, and narrative drafting with traceable user decisions.
Submit & learn
Prepare E2B(R3) data, monitor submission work, and connect cases to signal and aggregate-reporting workspaces.
E2B(R3) operations
Readiness without false certainty.
Prepare structured data, support XML validation, and make submission work visible across markets. Exact reporting scope is defined with your implementation and governance teams.
Discuss your deployment scopeSafety intelligence, connected.
Investigate emerging patterns across case, literature, signal, CAPA, and aggregate-reporting work—not in disconnected spreadsheets.
Designed for compliant operations
Automation that respects the safety system.
Human decisions stay accountable
AI suggestions are designed for review by authorized users—not as autonomous clinical or regulatory judgment.
Traceability is built into the workflow
Keep the context, review steps, and operational evidence needed for each safety decision connected.
Implementation starts with your operating model
Map products, markets, data, access controls, integrations, and validation activities before defining the rollout.
Start with the workflow
Plan a safety-system pilot with Vigilytics.
Bring the case volumes, markets, current systems, and operational priorities. We will map a practical pilot and implementation path together.