Opportunity
SAM #FDA-75F40126Q00317
FDA Seeks Support and Enhancements for DataFit (Pinnacle 21 Enterprise-Based) Data Standards Platform
Buyer
FDA Office of the Associate General Counsel for Administrative Law
Posted
August 07, 2026
Respond By
August 22, 2026
Identifier
FDA-75F40126Q00317
NAICS
541511, 541512, 541519
The Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER) and Office of Computational Science (OCS), is seeking comprehensive support for its DataFit data standards validation platform, which is based on Pinnacle 21 Enterprise software. - Government Buyer: - Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Office of Computational Science (OCS), Office of Translational Sciences (OTS) - OEMs and Vendors: - Pinnacle 21 (as the OEM of the core software platform) - Products/Services Requested: - Pinnacle 21 Enterprise License or equivalent solution (1 license) - Includes FDA-specific functionalities and integration with FDA systems - DataFit platform installation, maintenance, updates, and technical support - Development of FDA-specific enhancements and business rules - Project management, release management, configuration/change management, and system documentation - Operations and maintenance support, including user support and system performance - Compliance with CDISC data standards and Section 508 accessibility requirements - Key personnel roles: Bioinformatics Analyst III, Project Manager, Software Developer II, IT Technical Lead, Technical Writer, Trainer/Facilitator - Unique/Notable Requirements: - Solution must support FDA-specific business rules and reporting (CoreDF reports) - Integration with FDA systems and support for new CDISC standards - Combination of firm-fixed price and labor hour contract types - Up to three years of support with possible six-month extension - Emphasis on software release management, emergency patching, and documentation updates
Description
The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) requires support to install, update, support, and develop enhancements to maintain DataFit, CDER’s data standards validation platform.