Aggregate Reports refers to those reports that focus not so much on individual cases, but rather on overview, assessment of the safety profile and benefit-risk-evaluation. They comprise e.g.
- Periodic Safety Update Reports (PSURs) / Periodic Benefit Risk Evaluation Reports (PBRERs),
- Periodic Adverse (Drug) Experience Reports (US),
- Development Safety Update Reports (DSURs),
- Integrated Summaries of Safety (US), or
- Clinical Summaries of Safety (EU)
or safety related parts of Clinical Study Reports. These reports need special diligence and attention to detail on the one hand, overview and a sense of what is essential on the other hand.
We offer both. Our qualified personnel and our processes ascertain detailed and correct presentation of particulars. Our experience ensures the ability to find connections and to differentiate the essential from the routine. You (or a regulatory timeline) decide on the time frame up front – which turns into our deadline to which we adhere.
Before report finalization we discuss our results with you in the overall product context, including possible measures. If you decide to entrust us with the next PSUR or update RMP for the product, too, we will use the previous experience to assess the usefulness of these measures. And to create the new report even more effectively – possibly even more cost-effectively.
