PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support
Closed Pre-Solicitation Posted
- Solicitation number
- FDA-2026-132855
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- Not on record
- Place of performance
- St Neots Cambridgeshire United Kingdom
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA intends to award a sole-source task order to ENNOV (Assured Information Systems, Ltd.) for PVWorks Functions and FDA Adverse Event Monitoring support services, with a response deadline of May 19, 2026 and anticipated award on or about June 16, 2026.
The procurement covers one base year with two one-year option periods. ENNOV, located in Cambridgeshire, United Kingdom, is identified as the only commercial veterinary Pharmacovigilance vendor with both the CVM dictionary and VeDDRA dictionary of clinical terms installed, breed sub-registry capabilities, and compliance with VICH and CVM adverse event requirements. The contract requires comprehensive technical and consultation support to consolidate the legacy PVWorks suite (PV Express, PV Importer, PV Works, PV Admin, and PV Analyser) with the FDA's new Adverse Event Monitoring system. Work encompasses technical consultation support with dedicated subject matter experts; knowledge transfer to FDA AEM contractors and government staff; documentation of custom functions, database schemas, ETLs, data dictionaries, test plans, and user roles; document repository migration; and data analysis including gap analysis, mapping, extraction, transformation, and integration. The contractor must map PVWorks screens and reports to corresponding database structures, support all testing activities with traceability and verification, and ensure data integrity throughout migration. The NAICS code is 513210 (Software Publishers); PSC is DA01 (IT and Telecom – Business Application/Application Development Support Services). Firms believing they can meet the requirements may submit written responses by email to Alicia Baltimore at Alicia.Baltimore@fda.hhs.gov demonstrating capability to comply with the requirement.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| Notice of Intent.pdf | ||
| Attachment 1 - SOW_PV Works.pdf |
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