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Aggregate reports stay in the safety database
An aggregate report summarizes many cases over a period. A PSUR or PBRER covers a marketed product. A DSUR covers a drug still in development. An IND annual report is the FDA cousin of that development update. AE Connect does not write any of them.
Why this page exists
People searching for aggregate-report software often land on case-intake tools and assume the same login writes the periodic report. It does not. Individual cases still have to be complete before anyone can summarize them. That is the part AE Connect helps with: intake, a reviewed draft, and integration with any safety database. Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record. The database, or the partner who runs it, is where PSUR, PBRER, and DSUR authoring typically happens.
Oracle documents periodic reports as an Argus capability. Veeva's Safety Suite overview lists aggregate reporting. ArisGlobal describes reporting as part of LifeSphere Safety. Those products remain the system of record for aggregate reports. AE Connect integrates individual cases with any safety database. It does not write the PSUR, PBRER, or DSUR.
One SUSAR does not replace a DSUR. The PSUR, PBRER, and DSUR guide keeps the definitions in one place. The first-IND PV plan note covers the company core data sheet those reports depend on.
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Questions
Can AE Connect draft a PSUR or DSUR?
No. Aggregate writing is out of scope.
Do the cases in AE Connect roll into the report automatically?
No. The official case series is the one in the safety database.
What should we use AE Connect for, then?
Intake and AI case processing of the individual sources that later feed that series, with a person on every field.