Aggregate Safety Reports
Manage and harmonize your global Aggregate and Periodic Safety Reporting schedule, assign tasks, and manage oversight.
Harmonize periodic reporting
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.
- PBRER/ PSUR
- DSUR
- ACO
- IND
- Local reports
- and more
Oversight and scheduling
Global report harmonization 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
Webinars
Simplify & Harmonize Pharmacovigilance Aggregate Safety Reports
WEBINAR Simplify & Harmonize Pharmacovigilance Aggregate Safety Reports Thursday, 15
Holistic Visibility in Aggregate Safety Reporting: Centralize Scheduling for a Streamlined ASR Future
WEBINAR Holistic Visibility in Aggregate Safety Reporting: Centralize Scheduling for
Aggregate Safety Reporting Optimization: Start Automating at the Source for Downstream Continuity
WEBINAR Aggregate Safety Reporting Optimization: Start Automating At the Source
Blog
The Importance of Aggregate Safety Report Process Harmonization in Pharmacovigilance Operations
Pharmacovigilance is a critical part of ensuring patient safety and
From Reactive to Proactive: The Evolution of Aggregate Safety Reporting
The adoption of electronic reporting systems, increased collaboration between stakeholders, and changes in regulatory requirements have all contributed to this shift in proactive safety reporting.
Helping organizations move away from reactive Aggregate Safety Reporting
The Challenge The regulatory demands of guidance, PV Legislation, and
Connected trackers
Document Exchange
Automatically distribute reports to partners based on your Safety Data Exchange and PV Agreements.
Read more →Safety Commitments
Track Safety Commitments and Health Authority Requests related to report submissions and assessments.
See the webinar →Areas for Close Monitoring
With integrated MedDRA browsing, create consistent queries across reporting and data sciences teams.
Read more →