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AE Connect works with Veeva Vault Safety
AE Connect is not a Veeva Vault Safety alternative. Vault Safety remains the system of record. AE Connect integrates with Vault Safety and with any other safety database.
| Job | Safety database | What AE Connect adds in front |
|---|---|---|
| Role | Safety database. Veeva's Safety Suite overview describes Vault Safety as end-to-end management of intake, medical review, case processing, and submission, plus aggregate reporting. | Intake and AI case processing that integrates with Vault Safety. Vault Safety remains the system of record. |
| System of record | Typically Vault Safety, when the plan names it. Veeva describes it as a single source of truth for safety data on Vault. | No. |
| APIs | The same Veeva page says Vault Safety has open APIs and technology integrations. That is Veeva's platform, configured by the customer. | AE Connect integrates with Vault Safety. Vault Safety remains the system of record. |
| AI extraction and triage | Any automation inside a customer's Vault is their configuration. This page does not describe it. | Seriousness, expectedness, WHO-UMC causality, and a reporting timeline for a person to accept or override. |
| MedDRA coding assist | Coding in Vault uses the customer's MedDRA license. | A suggested preferred term and system organ class. |
| Narrative | Medical review in Vault Safety is where Veeva says the case is processed. | A short draft narrative to take into that review. |
| E2B(R3) output | Veeva describes submission of adverse events as part of Vault Safety. The gateway and the message are configured there. | AE Connect integrates the reviewed case with Vault Safety. Vault Safety remains the system of record for the E2B(R3) file. |
| Aggregate reports | Veeva's overview lists aggregate reporting in the Safety suite. SafetyDocs is a related content application. Generating tables still requires the Safety license, according to Veeva's SafetyDocs notes. | AE Connect does not write PSUR, PBRER, DSUR, or an IND annual report. |
Source: Veeva Vault Help, Veeva Safety Suite Overview. Veeva can change that page.
AE Connect integrates with any safety database. A reviewer accepts or overrides the draft, and the case integrates with the safety database. Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record.
Related: pricing, PV case intake, E2B(R3), trust.
Questions
Is AE Connect a Veeva Vault Safety alternative?
No. Vault Safety remains the safety database and the system of record. AE Connect integrates with it, and with any other safety database.
Does AE Connect integrate with Vault Safety?
Yes. AE Connect integrates with Vault Safety and with any other safety database. Vault Safety remains the system of record.
Who submits the ICSR?
The path configured in Vault Safety, or whichever partner your pharmacovigilance plan names. Not AE Connect.