Home / Works with / IQVIA Vigilance intake
Electronic AE / ICSR intake alongside IQVIA Vigilance Collect
AE Connect is a biotech electronic AE form and ICSR intake layer, comparable to IQVIA Vigilance Collect and Vigilance Intake. This is biotech AE intake alongside those products. It is not a full IQVIA Vigilance Platform and not an IQVIA services replacement. AE Connect is not affiliated with IQVIA, and this page does not claim integration with the IQVIA Vigilance Platform.
IQVIA describes Vigilance Collect as a web and mobile way for patients, healthcare professionals, pharmacies, support programs, and representatives to report an adverse event. IQVIA describes Vigilance Intake as intake automation on the Vigilance Platform: receiving adverse events, extracting data, and checking duplicates. Those are IQVIA products. AE Connect does that collect and intake job when the source is already in hand: electronic AE intake, an AI draft, and a person who accepts or overrides each field.
When IQVIA runs safety operations as the CRO, AE Connect is the intake workspace in front of the database the contract names. That is works-with language for the outsourced operation, not a Vigilance Platform integration and not a full-platform replacement.
| Job | IQVIA Vigilance Collect and Intake | What AE Connect does |
|---|---|---|
| Collect from a reporter | IQVIA's public page for Vigilance Collect describes a web and mobile portal that stores a submission and can create a case in a safety database. | Not that portal. The workspace is for a drug-safety reviewer working from a source they already received. |
| AE and ICSR intake | IQVIA's public page for Vigilance Intake describes automated receipt of adverse events on the Vigilance Platform, including extraction and duplicate search. | Electronic intake: paste or upload, a draft of seriousness, a suggested MedDRA term, causality, expectedness, and a timeline. A reviewer accepts or overrides every field. |
| Safety database and submissions | The Vigilance Platform is IQVIA's pharmacovigilance platform. Case processing, submissions, and the database stay there when the plan names them. | Out of scope for this page. AE Connect does not replace the Vigilance Platform and does not submit ICSRs. The safety database the plan names remains the system of record. |
Sources: IQVIA Vigilance Collect and IQVIA Vigilance Intake. IQVIA, Vigilance, Vigilance Collect, and Vigilance Intake are names of their owner. AE Connect is not affiliated with IQVIA. IQVIA can change those pages. This page does not describe, and does not replace, the rest of the Vigilance Platform.
If the safety database is Oracle Argus, ArisGlobal LifeSphere, or Veeva Vault Safety, use those pages: electronic intake for Oracle Argus, electronic intake for LifeSphere, and electronic intake for Vault Safety. When a CRO or PV partner holds the case, use PV partner intake.
Related: PV case intake, PV partner intake, PVA and SDEA, trust.
Questions
Is AE Connect an IQVIA Vigilance Platform alternative?
No. The Vigilance Platform stays the pharmacovigilance platform when the plan names it. This page is only the collect and intake job that Vigilance Collect and Vigilance Intake describe.
Is AE Connect Vigilance Collect or Vigilance Intake?
No. Those are IQVIA products. AE Connect is a separate electronic intake workspace for a source a reviewer already has.
Does AE Connect submit the ICSR?
No. Submission stays with the safety database or the partner the pharmacovigilance plan names.