Aggregate Safety Reports

Manage your global Aggregate and Periodic Safety Reporting schedule, assign tasks, and manage oversight.

Break down siloes

Your single source of truth for global aggregate reports.

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 cross-functional 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.

Oversight and scheduling

Global report oversight is within reach.

Orbit gives your team the tools needed to schedule and monitor upcoming aggregate safety reports across countries, products, and stakeholders.

Writing and submission

End-to-end workflow management.

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.

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.

Authoring and review workflows

Document Exchange Automation

Assessment Report Management



Connected trackers

Document Exchange

Automatically distribute reports to partners based on your Safety Data Exchange and PV Agreements.

Safety Commitments

Track Safety Commitments and Health Authority Requests related to report submissions and assessments.

Areas for Close Monitoring

With integrated MedDRA browsing, create consistent queries across reporting and data sciences teams.

Let's centralize your periodic reports.

Schedule a call today.