MasterControl SoftwareasaService for Electronic Tender - 132002255

Procurement Summary

Country: USA

Summary: MasterControl SoftwareasaService for Electronic Quality Management System

Deadline: 20 Dec 2025

Posting Date: 13 Dec 2025

Other Information

Notice Type: Tender

TOT Ref.No.: 132002255

Document Ref. No.: NIAID-NOI-26-2277932

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

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 NIAID-s Clinical Quality Management System (CQMS), which is responsible for managing controlled documents and quality processes related to NIAID-s 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 NIAID-s 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 l...
Notice ID: niaid-noi-26-2277932
Department/Ind. Agency: health and human services, department of
Sub-tier: national institutes of health
Office: national institutes of health niaid
Product Service Code: da10 - it and telecom - business application/application development software as a service
NAICS Code: 513210 - Software Publishers
Inactive Dates: jan 04, 2026
Inactive Policy: 15 days after response date

Documents

 Tender Notice