Manage your inventory of Risks (safety concerns)  in one place, from registration, risk categorization, risk management strategies, related minimization measures, including local RMMs - and other activities​

Built around a powerful workflow engine that allows for the creation, review and approval of risk management documents​

Utilize MedDRA queries collections that are standardized across modules, to ensure that terms and medical concepts are assigned, reviewed and maintained against the risk ​

Auto-generate core RMPs, local RMPs / REMS using formatted core and local Word templates with the capability to introduce controlled “Snippets” for non-core template text​

Monitor timeliness across all deliverables using built-in charts, including a Gantt overview of risk commitment activities​

Links with Signal modules for fully integrated signal & risk process​

Use in collaboration with Requirements Intelligence to ensure that risk management activities are in alignment with global regulatory requirements

Maintains an audit trail for all changes and updates

Is GxP validated* and ready to use in the cloud