SAM #HT9427-27-SSN-701

DHA seeks modification of Westat’s EZPLAZ clinical-trial work

The Defense Health Agency is seeking market-research responses for a planned sole-source modification to Westat Inc.’s SAFE-PLASMA clinical-trial work. - Government buyer: Defense Health Agency (DHA), through the Defense Health Agency Contracting Activity, for the Portfolio Acquisition Executive for Medical Products’ Warfighter Protection and Acute Care Project Management Office. - Named vendor: Westat Inc., the intended recipient of the planned sole-source modification. - Requested service: Modify the existing EZPLAZ clinical-trial design to address FDA recommendations and conduct a Good Clinical Practices-compliant trial consistent with FDA requirements for EZPLAZ approval. - The trial will evaluate the safety of EZPLAZ and conventional plasma products in adult patients. - Products and quantities: No product line items, quantities, or part numbers are specified. EZPLAZ and conventional plasma products are referenced as trial products. - Notable requirement: The work must support an FDA-compliant clinical trial and address FDA recommendations. No OEM/manufacturer is identified in the provided information.

Description

The Defense Health Agency Contracting Activity, on behalf of Portfolio Acquisition Executive for Medical Products, Warfighter Protection and Acute Care Project Management Office, intends to issue a contract modification on a sole-source basis with Westat Inc. 1600 Research Blvd. Rockville, MD 20850. This modification will enable Westat Inc. to modify the current clinical trial design to comply with FDA recommendations and to conduct the Good Clinical Practices (GCP) compliant clinical trial in accordance with U.S. Food and Drug Administration’s requirements for EZPLAZ™ approval.

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