Centralized Risk Register for Drug Safety

Track, evaluate, and manage safety risks with confidence.

A single source of truth for safety risks means faster decisions, fewer blind spots, and better compliance.

Transparency across teams – All stakeholders work from the same risk log, with real-time updates and audit trails.
Prioritized risk management – Use customizable scoring (likelihood, severity, detectability) to focus on what matters.
Integrated mitigation tracking – Assign owners, deadlines, and mitigation steps to ensure follow-through.
Inspection ready – Easily show regulators a structured, traceable approach to safety risk management.

Effortlessly link each safety risk to a Standardised MedDRA Query (SMQ) or custom MedDRA term set for consistent, automated signal detection.

Each risk mapped to a query – Ensures consistent surveillance of known or emerging safety issues.
Supports automation – Schedule signal runs using the linked MedDRA queries from your safety database.
Clear documentation – Build confidence during audits and inspections with query-to-risk traceability.

Link open risks to signals being tracked in Orbit’s signal module for unified monitoring.

Easily pull risks from the register into your RMP drafts and updates.

Track decisions from safety meetings (e.g., DSMC, BRAT) directly alongside risk updates.

Let us show you how easy it can be to stay compliant, aligned, and inspection-ready—across every market you operate in.