PVWORKS FUNCTIONS WITH FDA ADVERSE EVENT MONITORING (AEM) SUPPORT

The FDA intends to award a sole source task order contract to Assured Information Systems, Ltd., doing business as ENNOV for PV Works suite of tools, a pharmacovigilance system that CVM uses for receipt and evaluation of animal drug adverse events reports for both approved and unapproved animal drugs to support the FDA’s Adverse Event Monitoring System. ENNOV (formerly Assured Information Systems, Ltd.) is the only vendor that makes software and provides interfaces and screen customization for regulators and sponsors for veterinary Pharmacoviligence analytics.  ENNOV is the only commercial veterinary Pharmacoviligence vender that has installed both the CVM dictionary and the VeDDRA dictionary of clinical terms, breed sub-registry and meets the VICH and CVM adverse event requirements.