This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on May 12, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support

Closed

FDA-2026-132855Federal

Submission Closed05/19/2026, 04:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 518210

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about 23 hours ago

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AI Contract Overview

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 [email hidden].

General Info

FDA awards sole source contract to ENNOV for veterinary pharmacovigilance software and adverse event monitoring.

Agency

Department Of Health And Human Services → FDA Center For Veterinary Medicine

NAICS

518210 - Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

Place of Performance

St Neots, GB-CAM, GBR

Set-Aside

NONE

Documents

FDA CVM Consolidate PVWorks Functions Statement of Work

sow

High

FDA Notice of Intent for Sole-Source Task Order to ENNOV

presolicitation

Low

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedMay 12

Presolicitation

Response DeadlineMay 19

Deadline has passed

Submission Closed

05/19/2026, 04:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Center For Veterinary Medicine

Contacts1 person available

OfficeSilver Spring, MD, 20993, USA

Organization / AgencyDepartment Of Health And Human Services → FDA Center For Veterinary Medicine

Office AddressSilver Spring, MD, 20993, USA

Contacts

Alicia Baltimore

contact@example.gov

Full Description

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.