MasterControl Software-as-a-Service for Electronic Quality Management System
Location:
United States
Posted on:
Dec 15, 2025
Deadline:
Dec 20, 2025
Summary:
NIAID intends to award a sole source contract for MasterControl SaaS subscriptions to support its Clinical Quality Management System for clinical trials.
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This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm–fixed price purchase order under the authority of 41 U.S.C. 1901, as implemented by FAR 13.106–1(b)(2) and 13.501(a) – Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive quotes.The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate on a sole source basis with MasterControl Solutions 6350 Sth 3000 E Ste 520, Salt Lake City, UT 84121–5963. The Clinical Informatics Branch (CIB) supports NIAIDs Clinical Quality Management System (CQMS), which is responsible for managing controlled documents and quality processes related to NIAIDs role as a sponsor of clinical trials in a regulated environment. NIAID uses a cloud–based application to support the electronic Quality Management System (eQMS) maintained by multiple quality groups within in a validated environment in accordance with federal and international regulations. MasterControl Solution, Inc.s software has been used to support NIAIDs CQMS since 2019. This service allows protocols sponsored by NIAID to successfully manage their documentation, training, and navigate regulatory audits. The application establishes a system, identified as Clinical Quality Management System (CQMS), which contains essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced during those trials. Documents collected throughout the lifecycle of a clinical trial must serve to demonstrate compliance with the current standards of Good Clinical Practice (GCP) and all applicable regulatory requirements. NIAID requires the procurement of MasterControl software as–a–service (SaaS) subscriptions to support the NIAID CQMS Project. These licen
