Pharmacovigilance (PV)

Our Pharmacovigilance (PV) service provides support in the overall safety and risk/benefit assessment of your product.

We offer surveillance services to assist in all phases of clinical research. We provide experience, consistency and dedicated medical and safety staff. The service includes PV Setup (create study specific SOP addendums for clinical studies, create suitable drug safety system, EVWEB setup/sponsor registration), PV Processing (SAE initial report processing as per SOP, SAE follow-up report processing, Medical assessment, Electronic reporting via EMEA/CAs, Preparation of CIOMS reports, Submit CIOMS reports to CRO/client for reporting to Inv, EC & CAs) and Aggregate Data Reports (SUSAR Listing, medical review, EU Annual Report (ASR) Listing, EU ASR – Medical review and End-of-study listing for reconciliation).

CROS NT offers PV-System Hosting if desired. PV-Server can be hosted in our data centre adhering to the highest industry standards and qualified staff ensures highest availability of the applications.