PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support

The FDA Center for Veterinary Medicine intends to award a sole-source task order contract to Assured Information Systems, Ltd., doing business as ENNOV, for technical support services related to the PVWorks pharmacovigilance system, which is critical for the receipt, evaluation, and analysis of adverse event reports for animal drugs. ENNOV is the exclusive provider of the PVWorks software suite and the only vendor with installed and fully integrated CVM and VeDDRA dictionaries, meeting all VICH and CVM regulatory requirements for veterinary pharmacovigilance. The contract, solicited under FDA-2026-132855, has a posted date of May 12, 2026, with a response deadline of May 19, 2026, and is structured as a one-base-year contract with two optional one-year extensions, totaling up to three years of performance. The place of performance is located at ENNOV’s registered office in St Neots, Cambridgeshire, United Kingdom, while the contracting office is in Silver Spring, Maryland. The award is justified under FAR 5.201 and RFO 12.102(b) due to ENNOV’s unique proprietary access to the system’s source code, custom interfaces, business rules, and FDA-specific data mappings, which no other vendor can replicate. Key deliverables include comprehensive documentation of system architecture, database schemas, API specifications, ETL processes, data dictionaries, and automated test scripts, all in XML, CSV, XLSX, and PDF formats, adhering to FDA’s Electronic Product Life Cycle standards and regulatory frameworks. The contractor is also required to perform full data migration and validation using checksums and record counts, conduct structured knowledge transfer to FDA staff, and document all workflows, UI components, and mapping logic. No pricing details are disclosed, and the contract does not include formal FAR clauses, special socioeconomic certifications, or physical packaging requirements, as all work is purely digital and technical in nature. Point of contact for inquiries is Alicia Baltimore at Alicia.Baltimore@fda.hhs.gov.