Medidata Remote Source Review (RSR) Bridge Contract

Closed Pre-Solicitation Posted

Solicitation number
HHS-OMAS-2026-03
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

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute of Allergy and Infectious Diseases (NIAID), Office of Cyber Infrastructure and Computational Biology, intends to procure Medidata Remote Source Review (RSR) Software-as-a-Service on a sole-source basis from Medidata Solutions, Inc., with a capability statement deadline of June 4, 2026. This is a six-month bridge contract modification to existing contract 75N93026P00007 to ensure continuity of mission-critical clinical trial monitoring operations while a non-competitive procurement is prepared.

The procurement covers all software subscriptions, licenses, hosting, maintenance, updates, technical support, and related services necessary for authorized Government users and designated clinical trial stakeholders to access participant medical records and study source documents. NIAID justifies the sole source award on the determination that only Medidata publishes RSR software and that Medidata prohibits external parties from hosting their software. Service interruption would risk participant safety, delay adverse event identification, compromise data integrity, disrupt trial timelines, and delay regulatory submissions to the FDA and European Medicines Agency. Transitioning to alternative software could cause data loss, service downtime, and workflow disruption while requiring retraining of all authorized users and stakeholders.

All responsible sources may submit a capability statement by 3:00 PM EST on June 4, 2026, to Christopher Shih, Contracting Officer, at christopher.shih@hhs.gov. Contractors must be registered and maintain valid certification through SAM.gov. Reference HHS-OMAS-2026-03 on all correspondence. NAICS code 513210 applies, with a small business size standard of $47 million.

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 6 months, 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.

This acquisition is for a six-month bridge contract to ensure continuity of OCICB’s mission-critical cloud computing operations while a non-competitive procurement is prepared.

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 done as a modification under the current contract 75N93026P00007 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 June 4, 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-2026-03 on all correspondence.

Files

File Type Posted
Notice of Intent - Medidata RSR Bridge Contract.pdf PDF

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