PV case intake
The source document, the draft, and the person who accepts each field.
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Solutions
AE Connect is the intake form and AI case-processing layer that integrates with any safety database. Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record. These pages say what that covers.
AE and SAE intake form
An adverse event and a serious adverse event are not the same decision.
SUSAR triage
Serious, unexpected, and suspected. AE Connect integrates the case with the safety database, which remains the system of record.
PQC intake
A quality complaint that also describes an adverse event. Not a QMS.
E2B(R3)
Case concepts integrated with any safety database. Argus, ArisGlobal, and Veeva remain the system of record.
Aggregate reports
PSUR, PBRER, and DSUR stay with the safety database.