SAFETY SERVICES / 04
Aggregate Safety Reporting
Bring clinical and post-marketing safety evidence together in clear, scientifically reviewed reports.
Discuss this service
What this service covers
- DSUR support
- PSUR/PBRER support
- Safety narratives
- Periodic safety analyses
- Benefit–risk documentation
- Regulatory safety writing
Potential deliverables
- Report scope, schedule and source-data plan
- Draft safety reports and narratives
- Documented scientific review and comment resolution
What to bring to the discussion
- Reporting calendar and applicable report types
- Available safety and exposure data
- Authoring standards and approval responsibilities
Qualified specialists, delivery arrangements and responsibilities are agreed before contracting.
WHAT WE CAN SUPPORT
Expertise for your scope.
- DSUR support
- PSUR/PBRER support
- Safety narratives
- Periodic safety analyses
- Benefit–risk documentation
- Regulatory safety writing
Potential deliverables
- Report scope, schedule and source-data plan
- Draft safety reports and narratives
- Documented scientific review and comment resolution
Start with your context
- Reporting calendar and applicable report types
- Available safety and exposure data
- Authoring standards and approval responsibilities