Notice of Intent to Sole Source

The Food and Drug Administration (FDA) requires consultative and technical support services for Center for Veterinary Medicine’s (CVM’s) existing adverse event reporting system, Pharmacovigilance (PV) Works VET platform. The support is needed to obtain deliverables for FDA’s priority initiative of developing streamlined, consolidated enterprise-wide adverse event monitoring (AEM) system.

The PV Works suite of tools is the Pharmacovigilance (PV) system that CVM uses for receipt and evaluation of animal drug adverse events reports for both approved and unapproved animal drugs. Though PV Works VET suite is a customizable commercial product manufacturer as defined in Federal Acquisition Regulation (FAR) subpart 2.101, the software is proprietary to the original equipment (OEM) Ennov, doing business as Assured Information Systems (AIS).

The code and knowledge required by FDA to support the FDA AEM directive is unique to the OEM. The required services include validation of systems analysis documentation, mapping, data extraction and migration support.