PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support
The FDA plans to award a sole source contract to ENNOV for their PV Works pharmacovigilance system, used to manage animal drug adverse event reports. ENNOV is the only vendor providing veterinary pharmacovigilance software with necessary interfaces and screen customization for regulators and sponsors. They are uniquely equipped with both the CVM and VeDDRA dictionaries, a breed sub-registry, and compliance with VICH and CVM adverse event requirements. No specific timelines, budget amounts, or performance location are mentioned in the description. This opportunity is relevant for bidders interested in specialized veterinary pharmacovigilance software.