MasterControl Software-as-a-Service for Electronic Quality Management System NIAID-NOI-26-2277932

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 licenses are only available from MasterControl. The capabilities as described on the attached Bill of Materials for a 6-month period with a period of performance of 1/1/2026 to 6/30/2026. The North American Industry Classification (NAICS) code for this acquisition is 513210 Software Publishers, which has a size standard of $47.0 million. Medidata Solutions is an other than small business. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within fifteen (15) days of this notice. While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The Government understands that MasterControl software as-a-service (SaaS) subscriptions is the only vendor who can provide the requested services for NIAID. However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within 10 days after publication of this notice. Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested parties may identify their interest and capability to respond to the requirement or submit offers on NOI-NIAID-26-2277932. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Linda Smith, Contracting Officer at Linda.smith2@nih.gov.

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 licenses are only available from MasterControl. The capabilities as described on the attached Bill of Materials for a 6-month period with a period of performance of 1/1/2026 to 12/31/2026. The North American Industry Classification (NAICS) code for this acquisition is 513210 Software Publishers, which has a size standard of $47.0 million. Medidata Solutions is an other than small business. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within fifteen (15) days of this notice. While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The Government understands that MasterControl software as-a-service (SaaS) subscriptions is the only vendor who can provide the requested services for NIAID. However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within 10 days after publication of this notice. Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested parties may identify their interest and capability to respond to the requirement or submit offers on NOI-NIAID-26-2277932. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Linda Smith, Contracting Officer at Linda.smith2@nih.gov.