Centralized Risk Register for Drug Safety
Orbit’s Risk Register is built for modern pharmacovigilance teams, offering a centralized, auditable system to capture, monitor, and act on risks across the entire drug development lifecycle.
Centralized Risk Register
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.
MedDRA Query Integration
Achieve consistency for risks across the product lifecycle
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.
Connected trackers
Safety Surveillance
Link open risks to signals being tracked in Orbit’s signal module for unified monitoring.
Read more →Risk Management Plans
Easily pull risks from the register into your RMP drafts and updates.
Read more →Benefit Risk
Track decisions from safety meetings (e.g., DSMC, BRAT) directly alongside risk updates.
Read more →Ready to manage your risk register?
Let us show you how easy it can be to stay compliant, aligned, and inspection-ready—across every market you operate in.
