Medidata Remote Source Review (RSR)
Closed Pre-Solicitation Posted
- Solicitation number
- HHS-OMAS-2027-03
- Agency
- Not on record
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 513210 Software Publishers
- Place of performance
- Rockville, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health under the Department of Health and Human Services, intends to procure Medidata Remote Source Review (RSR) Software-as-a-Service for Clinical Trial Monitoring on a sole-source basis from Medidata Solutions, Inc., with responses due September 29, 2026. The procurement covers a base period of one year with two one-year options, encompassing all software subscriptions, licenses, hosting, maintenance, updates, technical support, and related services. Medidata is the sole source available because it is the original publisher of the RSR software and does not permit other vendors to provide hosting services.
The incumbent contract (75N93026P00007) expires December 31, 2026. The RSR platform is mission-critical for secure remote access to participant medical records and clinical trial monitoring; any service interruption potentially compromises participant safety, data integrity, and regulatory submissions.
Work is performed at Medidata Solutions' location in New York and serves designated clinical trial stakeholders and authorized Government users throughout the performance period. NAICS code 513210 (Software Publishers) applies, with a small business size standard of $47 million. PSC code is DA10.
Although this is a sole-source procurement, all responsible sources may submit a capability statement demonstrating ability to fulfill requirements. Contractors must be registered and maintain valid certification through SAM.gov. Responses should be submitted in writing to Christopher Shih, Contracting Officer, at christopher.shih@hhs.gov.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| NOI - Medidata RSR FY27.pdf |
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