Think Trends Software Implementation and Support

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.