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.
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.
Manage reporting projects, calculate milestones and deadlines, and harmonize your global reporting schedule. Orbit’s automated aggregate safety report scheduler makes predicting and monitoring your team’s workload straightforward.
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.
WEBINAR Exchanging safety documents with partners: how to reduce complexity
WEBINAR Aggregate Safety Reporting – meeting the challenges of a
Introduction Aggregate safety reporting is an essential component of drug
The Challenge The regulatory demands of guidance, PV Legislation, and
Most Pharma companies rely on passive tools—such as spreadsheets and
Automatically distribute reports to partners based on your Safety Data Exchange and PV Agreements.
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.