PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support

The FDA plans to award a sole source task order contract to Assured Information Systems, Ltd., operating as ENNOV, for the PV Works suite of tools. This pharmacovigilance system is used by the Center for Veterinary Medicine (CVM) to receive and evaluate adverse event reports related to both approved and unapproved animal drugs. The contract supports the FDA’s Adverse Event Monitoring System by utilizing ENNOV’s proprietary software, which is uniquely customized for regulators and sponsors in veterinary pharmacovigilance analytics. ENNOV stands out as the sole vendor providing this specialized software with critical features such as integration of the CVM and VeDDRA dictionaries of clinical terms, breed sub-registry functionality, and compliance with VICH and CVM adverse event requirements. The contract, titled "PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support," is a presolicitation issued by the FDA Center for Veterinary Medicine under the Department of Health and Human Services. The contract will be managed from the FDA office in Silver Spring, Maryland, with performance located in St Neots, Cambridgeshire. Interested parties had until May 19, 2026, to respond to the solicitation issued on May 12, 2026. The primary contact for this procurement is Alicia Baltimore, who can be reached via email at the FDA. This initiative underscores the FDA's commitment to maintaining a robust veterinary drug safety monitoring system through a collaborative partnership with ENNOV.