SAM #HHS-OMAS-2027-03

Medidata Remote Source Review (RSR) SaaS for Clinical Trial Monitoring

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Office of Cyber Infrastructure and Computational Biology (OCICB) is seeking Medidata Remote Source Review (RSR) Software-as-a-Service (SaaS) for clinical trial monitoring. - Government Buyer: - HHS NIH NIAID OCICB - OEM Highlight: - Medidata Solutions, Inc. is the sole source provider - Products/Services Requested: - Medidata Remote Source Review (RSR) SaaS - Includes software subscriptions, licenses, hosting, maintenance, updates, technical support, and related services - Quantity: 1 (annual subscription) - No specific part number provided - Unique Requirements: - Sole source procurement; Medidata Solutions, Inc. does not permit other vendors to host or resell this solution - Solution must ensure uninterrupted access and functionality for authorized government users and clinical trial stakeholders - Period of Performance: - One-year base period with two one-year option periods (up to three years total)

Description

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Office of Cyber Infrastructure and Computational Biology (OCICB), intends to procure services for a base period of performance of one year with two (2), one-year options, on a sole source basis, for Medidata Remote Source Review (RSR) Software-as-a-Service for Clinical Trial Monitoring, including all software subscriptions, licenses, hosting, maintenance, updates, technical support, and related services, from Medidata Solutions, Inc., 9th Floor 350, Hudson Street, New York, NY 10014-4535.

To provide adequate service, the vendor must shall provide Medidata Remote Source Review (RSR) as a software-as-a-service (SaaS) solution, including all software subscriptions, licenses, hosting, maintenance, updates, technical support, and related services necessary to ensure uninterrupted access and functionality for authorized Government users and designated clinical trial stakeholders throughout the period of performance.

The publicizing of this notice is in accordance with Revolutionary Federal Acquisition Regulation (RFO) 5.101(a). This will be non-competitive solicitation based on the Contracting Officer's determination that only one source is available to meet the Government's requirements due to the only one-source for RSR software and Medidata does not allow other vendors to provide hosting services. The applicable North American Industry Classification System (NAICS) code is 513210 – Software Publishers, and the associated small business size standard is $47 million.

This notice is not a request for competitive quotations. However, all responsible sources may submit a capability statement, which will be considered by the agency. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow the Office of Mission Acquisition Solutions (OMAS) to determine if the party can fulfill the requirement.  All responses must be sent via email to Christopher Shih, Contracting Officer at christopher.shih@hhs.gov by no later than 3:00 PM EST on September 29, 2026.

A determination by the Government not to modify the current award is based upon responses to this notice is solely within the discretion of the Government. To receive an award, contractors must be registered and have valid certification through SAM.gov. Reference HHS-OMAS-2027-03 on all correspondence.

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