SAM #FDA-SS_2026-040726

FDA Market Research for ThinkTrends Software Implementation and Support

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking information from vendors for the implementation and support of ThinkTrends software to modernize FDA operations. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Contracting office: FDA Office of Acquisition & Grant Services, Rockville, MD - OEMs and Vendors: - ThinkTrends (only OEM mentioned) - Products/Services Requested: - Implementation and integration of ThinkTrends software - Advanced data management (migration, integration, cleansing, cataloging, data lakes/mesh) - Integration of emerging technologies (RPA, AI-based OCR, blockchain, edge computing, generative AI, NLP, LLMs) - Intelligent question-answering, advanced visualization, analytics, and workflow automation - FDA system enhancements (FAERS support, document digitization) - Data-driven tools and user experience improvements - Comprehensive support: ThinkTrends license acquisition, agile project management, staff training - Unique/Notable Requirements: - Emphasis on leveraging AI, automation, and emerging technologies - Focus on enhancing regulatory processes and operational efficiency - No specific part numbers or quantities provided - This is a sources sought notice for market research, not a formal solicitation

Description

Sources Sought Notice:

1. Purpose

The FDA is conducting market research to identify capable vendors to support the implementation and integration of ThinkTrends software and related human interventions across FDA operations. This enhanced effort will leverage Artificial Intelligence (AI), automation, and emerging technologies to improve operational efficiency, data management, and regulatory processes.

This Sources Sought notice is for information and planning purposes only and is not a solicitation. Responses will be used to determine the availability of qualified vendors and to inform future acquisition strategy, including potential sole-source justification or competitive procurement.

Background

The BPA will support FDA’s efforts in:

Advanced Data Management: Data migration, integration, cleansing, cataloging, annotation, and implementation of data lakes or data mesh architectures. Emerging Technology Integration: RPA, AI-based OCR (>90% accuracy), blockchain, edge computing, generative AI, NLP, and LLMs for document summarization. Intelligent Question-Answering: AI-assisted drafting of regulatory responses, highlighting issues, and providing contextual/historical data. Advanced Visualization & Analytics: Interactive dashboards, predictive analytics, and virtual/augmented reality for data visualization. Automation & Process Enhancements: Workflow automation, AI-driven quality control, and regulatory tracking. FDA System Enhancements: Next-generation OCR, FAERS support with AI signal detection, and intelligent digitization of document rooms. Data-Driven Tools: AI decision support, predictive models, and digital twins to optimize regulatory processes. User Experience Improvements: Intuitive AI-assisted interfaces, personalized dashboards, and voice-activated assistants. Comprehensive Support: ThinkTrends license acquisition, agile project management, and continuous staff training.

Continues on the attached document.

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