PVA means pharmacovigilance agreement. It is a written agreement that divides pharmacovigilance duties between parties, such as a sponsor and a partner, or a licensor and a licensee. An SDEA is a safety data exchange agreement. It describes how safety data, including adverse event reports and ICSRs, moves from one party to the other: who receives a report, and what has to be in it. PVA is not a software product. An SDEA is not a software product.
The agreement can be clear and the case can still arrive as email. A valid case, and the point at which Day 0 can start, still needs an identifiable patient, an identifiable reporter, a suspect product, and a suspect reaction. That gate is the one in the Day 0 note. What late intake does is the process description of what happens when those facts are missing or late. This note does not add a clock, and it does not estimate harm from a late exchange.
Pharmacovigilance agreement intake form
A pharmacovigilance agreement intake form is the structured record of the adverse event exchange the SDEA describes. That is partner ICSR intake. AE Connect is electronic intake for that case: the receiving reviewer pastes or uploads the source, accepts or overrides the draft, and the case can go to the safety database the agreement names. PVA is not software, and this is not a PVA product page. AE Connect does not replace the agreement, does not decide which party owns the clock, and does not submit the ICSR.
The database might be Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, or another system. The collect and intake job beside IQVIA Vigilance Collect and Intake is not an IQVIA Vigilance Platform alternative. When the other party is a CRO or a pharmacovigilance service partner, the intake page is PV partner intake. PrimeVigilance and PharmaLex are examples of that kind of partner. They are not alternatives to AE Connect, and AE Connect is not affiliated with them.