Aggregate reports provide periodic review of safety data in a global and cumulative way instead of looking at individual cases. While the concept is simple, the process can become complex to manage. To understand the benefit-risk profile of a product, the process requires the collection and assessment of safety data, as well as handling the necessary aggregate reports across a product’s lifecycle in various markets.
The Med Communications Pharmacovigilance (PV) team provides complete end-to-end management of all aggregate report types including, but not limited to, the Periodic Adverse Drug Experience Report (PADER or PAER); the Periodic Benefit Risk Evaluation Report (PBRER); the legacy Periodic Safety Update Report (PSUR), which is still used in some markets; and Investigational New Drug (IND) Annual Reports, especially where there is no Development Safety Update Report (DSUR) waiver available. Our PV services include periodic submission of individual case safety reports (ICSRs) to the appropriate regulatory authorities in support of the aggregate reports. Our PV team can also handle ad hoc report requests, such as Suspected Unexpected Serious Adverse Reaction (SUSAR)/Serious Adverse Event (SAE)/Adverse Event (AE) line listings, AE summary tabulations, and CIOMS II line listings, for clients and regulatory authorities.
Aggregate reports project management assists clients with templates, data retrieval/requests, the review process, and timelines to facilitate the contribution of the different stakeholders involved in the process and to assure compliance with submission deadlines. To analyze the data and draft the content of the required reports, our experienced PV professionals query the safety database to retrieve the necessary data and listings to be analyzed and review the additional information provided by the client. As a standard to the aggregate reports process, the PV team employs internal quality and medical reviews before submitting the reports to the client for their review and approval.
Our PV team will use their expertise and all available tools to assist clients with forecasting the reports required for each market and product and with planning the appropriate reporting periods, data lock points, and submission dates for each regulatory authority.