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Electronic intake for sponsors working with a PV partner or CRO

This is PV partner intake and CRO case intake: ICSR intake your team or your CRO uses. It works with Argus, Vault Safety, and LifeSphere. Cases still land in those safety databases. PrimeVigilance and PharmaLex are example PV service models only, not alternatives and not affiliations.

PrimeVigilance case intake

PrimeVigilance case intake, on this page, means an intake form for PrimeVigilance clients: the sponsor's reviewer captures the adverse event before the partner processes it. It is ICSR intake beside that partner workflow. It is not a PrimeVigilance product and not a claim that AE Connect is inside PrimeVigilance's systems.

PharmaLex ICSR and AE intake

PharmaLex ICSR intake, here, is electronic intake with PharmaLex PV when PharmaLex is the service partner named in the agreement. The same limit applies: AE Connect does not replace PharmaLex, and it does not connect to a PharmaLex system unless that path is agreed separately. The safety database remains the system of record.

The partner is named in the pharmacovigilance agreement. The agreement, and the safety data exchange agreement inside it or beside it, says who receives an adverse event and what has to be in the report. The case can still arrive as email. Intake is the step that turns that source into a reviewed draft before it sits in the partner's safety database, or before a case the partner processed comes back to the sponsor.

What the reviewer does

Paste the narrative or upload the file. Parsing runs in the browser. The draft covers seriousness, a suggested MedDRA term, causality, expectedness, a timeline, and a short narrative. A qualified person accepts or overrides every field. AE Connect does not decide which party owns the reporting clock, and it does not submit the ICSR.

Where the case goes

Into the safety database the agreement names. That may be Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, or another database, including one a partner hosts. The collect and intake job beside IQVIA Vigilance Collect and Intake is a different page, and it is not an IQVIA Vigilance Platform alternative. The database remains the system of record.

PrimeVigilance and PharmaLex are names of their owners. AE Connect is not affiliated with them. Naming them here only says what kind of organization a pharmacovigilance agreement might point to.