PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The FDA Center for Veterinary Medicine (CVM) intends to award a sole-source task order contract to Assured Information Systems, Ltd. (doing business as ENNOV) for PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support. This presolicitation is for specialized pharmacovigilance system support, with ENNOV identified as the only vendor capable of meeting the unique requirements. Firms believing they can meet these requirements must submit a response by May 19, 2026, 12:00 PM ET.
Purpose & Scope
The U.S. Food and Drug Administration (FDA) requires consultative and technical support services for the Center for Veterinary Medicine's (CVM) existing adverse event monitoring and reporting system, the "Pharmacovigilance (PV) Works VET platform." This effort supports the transition from legacy PVWorks systems to the FDA Adverse Event Monitoring System (AEMS).
ENNOV is considered the sole source due to its unique capabilities, including:
- Being the only vendor providing software, interfaces, and screen customization for veterinary pharmacovigilance analytics.
- Having installed both the CVM dictionary and the VeDDRA dictionary of clinical terms, breed sub-registry, and meeting VICH and CVM adverse event requirements.
The scope of work includes:
- Consulting with business and FDA AEM teams.
- Integrating PVWorks data with the FDA AEM system.
- Data extraction, transformation, and loading (ETL).
- Mapping PVWorks screens and reports to database structures.
- Providing data dictionaries and datasets.
- Documenting FDA customizations and business rules.
- Supporting testing activities and developing test plans.
- Transferring PVWorks knowledge to AEM contractors and government staff.
Contract Details
- Contract Type: Sole-Source Task Order (Presolicitation)
- Duration: One base year and two one-year option periods.
- NAICS Code: 513210 - Software Publishers.
- Product Service Code: DA01 - Support Services For Activities Involved With Application Development And Support To Include Analysis, Design, Development, Coding, Testing, And Release Packaging, As Well As Support Of Off The Shelf Business Applications.
- Anticipated Award Date: On or about June 16, 2026.
- Place of Performance: St Neots, United Kingdom (Contractor's location).
Set-Aside & Eligibility
This is a sole-source announcement, and no set-aside is planned at this time.
Submission & Deadlines
This is NOT a request for competitive quotations. However, any firm believing it can meet these requirements may submit a written response via email to Alicia Baltimore (Alicia.Baltimore@fda.hhs.gov) no later than May 19, 2026, at 12:00 PM Eastern Time (ET). Supporting evidence must demonstrate the firm's ability to comply with the requirements. The Government's decision not to compete the acquisition based on responses is at its sole discretion. Questions should also be directed to Alicia Baltimore.