SAM #FDA-2026-132855

FDA CVM Sole Source Support for ENNOV PVWorks Pharmacovigilance System and Data Migration

The FDA Center for Veterinary Medicine (CVM) is seeking specialized technical and consultative support to transition from its legacy ENNOV PVWorks pharmacovigilance system to the FDA Adverse Event Monitoring (AEM) system. - Government Buyer: - Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of Surveillance and Compliance (OSC) - OEMs and Vendors: - ENNOV (Assured Information Systems, Ltd.) - Products/Services Requested: - ENNOV PVWorks Pharmacovigilance System (veterinary adverse event monitoring software) - Includes interfaces, screen customization, CVM and VeDDRA clinical term dictionaries, breed sub-registry, and compliance with VICH and CVM adverse event requirements - Technical and consultative support services for PVWorks and its integration with FDA AEM - Data mapping, migration, extraction, transformation, validation, and documentation - Knowledge transfer, testing, and support for integration - Data cleanup, VeDDRA coding, code list harmonization, and adherence to regulatory standards - Documentation of custom functions, queries, reports, business rules, workflows, and user roles - Migration of document repositories and attachments - Data analysis, gap analysis, and support for data import/export - Integration requirements analysis and API/library support - Unique or Notable Requirements: - ENNOV is the only vendor capable of providing the required PVWorks system and related services - System must support specialized veterinary pharmacovigilance analytics and regulatory compliance - Customization for both regulatory and sponsor use, with unique clinical term dictionaries and breed sub-registry - Comprehensive technical support for data integrity and migration to the FDA AEM system - Period of Performance: - One base year with two one-year option periods (up to three years total) - Primary Places of Performance and Delivery: - FDA Center for Veterinary Medicine, Silver Spring, MD (federal facility) - Contractor location: St Neots, Cambridgeshire, United Kingdom

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.

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