Think Trends Software Implementation and Support

HEALTH AND HUMAN SERVICES, DEPARTMENT OF · FOOD AND DRUG ADMINISTRATION · FDA OFFICE OF ACQ GRANT SVCS is soliciting Think Trends Software Implementation and Support. Solicitation number 75F40126R00097. Classified under NAICS 541511 — Custom Computer Programming Services. Product/service code DA01 — IT AND TELECOM - BUSINESS APPLICATION/APPLICATION DEVELOPMENT SUPPORT SERVICES (LABOR). Place of performance: MD, USA. Responses are due by 28 September 2026 17:00 UTC. Posted on SAM.gov, the US federal contract opportunities system; registration is required to bid.

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.