AI Summary
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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