Pharmaco-vigilance Adverse Event Reporting

The United States Department of Agriculture's Animal and Plant Health Inspection Service, Veterinary Services division, plans to issue a sole source contract to Ennov, Assured Information Systems Limited, based in the United Kingdom. This contract aims to upgrade the existing software from PV-Express I to PV-Express II and implement a secure transfer system for electronic Adverse Event Reports submitted by regulated biologic firms. These reports feed into the Center for Veterinary Biologics' Pharmacovigilance system, which operates on proprietary PV-Works software already maintained by Ennov under a previous agreement. The proprietary nature of the PV-Works and PV-Express software, both copyrighted by the Ennov Group, necessitates this sole source procurement. This procurement is conducted under the Federal Acquisition Regulation (FAR) 6.302-1, which authorizes sole source contracts when only one responsible source can fulfill the agency's requirements. The contract falls under NAICS code 541519, covering Other Computer Related Services. The place of performance is in Ames, Iowa, with Bonnie K. Simpson serving as the contact person for the solicitation. The contract was publicly posted in July 2017, reflecting the USDA's intent to negotiate exclusively with Ennov due to the specialized nature of the deliverables and the proprietary software involved.