Seamless tracking for Aggregate Safety Reports
Manage your global Aggregate Safety Report schedule, assign tasks and manage oversight of Aggregate Reporting
Bridge the gaps in siloed Aggregate Reporting Processes
Aggregate Safety Reporting is one of the core functions of Global Patient Safety. Despite the existence of reporting tools, the process remains disjointed and difficult to manage with siloed systems, complex handoffs and repetitive manual work.
Orbit’s validated Aggregate Safety Reporting tools takes the guesswork out of Aggregate Reporting, boosting your team’s efficiency with streamlined workflows and automated scheduling. Track the completion of all of your reports: PADER, PSUR/PBRER, DSUR, RMPs and other safety documents.
Report scheduler keeps your team ahead of deadlines
Set the frequency on your Periodic Reports and allow Orbit to schedule upcoming tasks, deadlines, contributions, submissions and other activities around your Data Lock Point.
Powerful oversight and harmonization
Orbit's oversight tools provide insight into upcoming work, keeping your team ahead. Proactively monitor Reporting Activities across your global team with interactive data visualizations.
Track Assessment Report Activities
Orbit captures feedback and follow-up actions from regulators to ensure that you are staying ahead of commitments from Assessment Reports and other health authority requests.
Reporting Workflow
- Assign key report stakeholders, internal deadlines, and regulatory timelines
- Track document drafting and review
- Capture Internal Approval
Minimize Data Entry
- Structured data management to reuse timelines and content
- Integration with Orbit's DocXchange system notifies partners of new Safety Documents
Manage Contractors
- Manage contracted aggregate safety reporting work
- Integrate data from diverse data sources
- Centralize oversight of authoring, review and submission
