What to Know
Unlike individual case reporting, which uses deep data, aggregate safety reporting takes a higher level perspective developed over months or years. Submissions such as periodic reports and clinical findings must be managed continuously. ASR examines the overall safety and benefit-risk balance for your pharmaceutical product.
The key to aggregate reporting is to know what is important to regulatory entities and how to present it. ASRs must retain the abstract approach while discussing the relevant details. ASRs often require tailoring to satisfy expectations for specific countries.
How We Can Help
Our consultants come to you uniquely qualified to develop all clinical and marketed periodic reports. Some of the documentation we commonly prepare includes:
- Safety profile and risk-benefit analysis
- Country-specific safety reporting
- All planned regulatory responses
- PSUR Safety Update reporting
- Integrated safety summaries (US)
- Clinical safety summaries (EU)
We also offer expertise on Individual Case Safety Reporting. Contact us to ask a question or get connected with the right consultant for your team.