Preparation of aggregate reports (PBRER, PADER, DSUR, PSUR)
One of our key services is the preparation of both pre approval and post approval aggregate reports. Aggregate reports provide the world wide safety experience of the drug and also it allows the regulators to assess the qualitative and quantitative benefit / risk ratio of the drug, volume of prescriptions, number of patients exposed and actions taken for safety reasons.
Pharmacovigilance Network
Conclusion drawn from the aggregate reports are legally binding. Our medical writing team has expertise in drafting aggregate reports, by assessing the line listings or CIOMS forms. Aggregate reporting regulations have recently undergone a revision across the European Union. It is only a matter of time before the revisions are accepted and mandated globally to further strengthen the signal detection system and optimize the use of resources across the pharmacovigilance network for the benefit of public health.
We help you to meet regulatory requirements for aggregate reporting with the help of our.
closely aligned scientific writing and pharmacovigilance teams, to support aggregate reporting and safety writing for all stages of the product life cycle. We have also helped customers by having our aggregate reporting team harmonize with their case processing partner to provide quality aggregate reports.