SAM #FY2026SENDOMAS-IT

FDA CDER Solicits Annual License and Support for SEND Explorer Warehouse or Equivalent Software

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Computational Sciences (OCS), is seeking to procure software and support for nonclinical data review: - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Office of Computational Sciences (OCS) - Products/Services Requested: - Annual license for SEND Explorer Warehouse software, or an equivalent solution - To be deployed across Development, Test, Production, and Pre-production environments - Quantity: 1 annual license - Annual technical support for the software - Includes user support, software upgrades, installation, configuration, real-time consulting, online training, troubleshooting, and performance tuning - OEMs and Vendors: - No specific OEMs or vendors are named; SEND Explorer Warehouse is referenced as the baseline solution - Unique/Notable Requirements: - Software must support the nonclinical review of CDISC-SEND submissions - Must provide deployment documentation, software updates, and bug fixes - Delivery to FDA's Office of Computational Science in Silver Spring, MD - Contract period is for one year, with all services and support included - Equivalent solutions to SEND Explorer Warehouse are acceptable if they meet all requirements

Description

The Center for Drug Evaluation and Research (CDER) of the U.S. Food And Drug Administration (FDA) requires software to support the nonclinical review of CDISC- SEND submissions. The purpose of this requirement is to provide OCS with a Send Explorer Warehouse license on Development Environment, Test Environment, Production, and Pre-production, or equal to software solution with technical support. Please reference attached Statement of Work for exact specification.

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