SAM #75F40126R00097

FDA Solicitation for ThinkTrends Software Implementation, Licensing, and Support Services

The U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking a single-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract for comprehensive support and implementation of the ThinkTrends software environment. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Office of Acquisitions & Grant Services - OEM Highlight: - ThinkTrends is the sole Original Equipment Manufacturer (OEM) referenced for software and related services - Products and Services Requested: - ThinkTrends software licenses (annual acquisition and installation) - Technical and programmatic services for ThinkTrends software, including: - Implementation, integration, enhancement, maintenance, and sustainment - Application and system integration - Data migration and engineering - Document AI and NLP capabilities - Workflow automation - AI/ML lifecycle management - Analytics and advanced visualization - Digitization of regulatory documents - Integration with FDA systems - Application development - Security and compliance (including accessibility standards) - Agile project management - Training and continuity support - Project and program management (strategic planning, governance, stakeholder engagement, risk/change management) - Consulting and IT labor categories (each staffed with 1 FTE): - IT Project Manager II - Data Scientist II & III - Business Analyst II & III - Software Engineer II & III - System Analyst II & III - Test Engineer II & III - Management Consultant II & III - Unique/Notable Requirements: - AI-driven data management, OCR, and regulatory process automation - Compliance with FDA security and accessibility standards - Offerors must secure all necessary rights, licenses, and access to proprietary resources - Total Small Business Set-Aside under NAICS 541511 (Custom Computer Programming Services) - Contract value up to $49 million over five years, with a $2,500 minimum guarantee - Base year plus four option years, with possible 6-month extension

Description

ThinkTrends Software Implementation and Support IDIQ

The U.S. Food and Drug Administration (FDA) hereby issues Request for Proposals (RFP) No. 75F40126R00097 for ThinkTrends Software Implementation and Support services.

The Government intends to award one Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide technical and programmatic services supporting the implementation, integration, enhancement, maintenance, licensing support, and sustainment of the ThinkTrends software environment across FDA operations.

The resulting contract will provide a contractual vehicle through which FDA may issue task orders for specific requirements within the scope of the IDIQ.

This acquisition is a Total Small Business Set-Aside pursuant to FAR 19.502-2(b).

The applicable NAICS code is 541511 – Custom Computer Programming Services, with a size standard of $34 million in average annual receipts.

Only eligible small business concerns meeting the applicable requirements of the solicitation may submit proposals.

DESCRIPTION OF REQUIREMENT

The contractor shall provide comprehensive technical expertise to support ThinkTrends software implementation and related activities across FDA operations.

The requirement includes, but is not limited to:

ThinkTrends software implementation, configuration, enhancement, maintenance, and support; Application and system integration; Data migration, integration, cleansing, cataloging, and engineering; Document AI, OCR, ICR, and NLP capabilities; RPA and intelligent workflow automation; AI/ML lifecycle management and related MLOps activities; Analytics, visualization, dashboards, and decision-support capabilities; Digitization and conversion of regulatory documents and adverse event reports; Integration with FDA systems and data sources; Application development and enhancement; Security, compliance, validation, auditability, and operational support; Agile project and program management; Training and knowledge transfer; Transition and continuity-of-operations support; and ThinkTrends software license acquisition and installation support, as applicable to individual task orders.

Specific requirements and performance standards are provided in Section C – Statement of Work and the other solicitation documents.

 EXISTING THINKTRENDS ENVIRONMENT

FDA currently utilizes ThinkTrends capabilities in certain regulatory tools and systems, including the FDA Adverse Event Reporting System (FAERS), Site Selection Tools, and the BIMO Evaluation Support Tool (BEST).

Performance under the resulting contract will require the successful offeror to work within the Government's existing ThinkTrends environment and applicable FDA technical, security, data, integration, and operational environments.

Where performance requires software licenses, proprietary technical information, platform access, interfaces, documentation, or other third-party-controlled resources, the contractor shall obtain and maintain all rights, licenses, permissions, access, and authorizations necessary to perform the contract requirements.

Offerors shall address their approach to obtaining and maintaining any such resources as required by the solicitation.

View original listing