We have extensive experience in:
- Periodic Benefit/Risk Evaluation Reports (PBRERs)
- Periodic Safety Update Reports (PSURs)
- Post-Marketing Safety Report
- Integrated Summaries of Safety (US)
- Canadian Aggregate Reports (CARs)
- Summary Bridging Reports (SBRs)
- Periodic Adverse Drug Experience Reports (PADERs)
- PRAC/Health Authority Responses
- Developmental Safety Update Reports (DSURs)
- Benefit/Risk Profile Reports
- Literature Search, Analyses, and Ad-Hoc Benefit/Risk Assessments
- Data Analysis and Risk Communications
- Subject Matter Expertise for Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
- Risk Minimization Plans (RMP)
Over the years of our service, we have excelled in managing the aggregate report authoring and submission process. We partner with our clients in:
- Maintenance of the Aggregate Reporting Calendar
- Generation of Listings from the Pharmacovigilance Database
- Technical and Medical Review of the Reports
- Response to Health Authority Queries