This Presolicitation opportunity from Department Of Health And Human Services was posted on September 21, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Medidata Remote Source Review (RSR)

Closed

HHS-OMAS-2027-03Federal

Submission Closed09/29/2026, 08:00:00 PM EDT

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 513210

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Solicitation # N0017327Q1301424824

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AI Contract Overview

The Department of Health and Human Services, through the National Institutes of Health and the National Institute of Allergy and Infectious Diseases, intends to procure Medidata Remote Source Review (RSR) as a Software-as-a-Service solution for clinical trial monitoring. This mission-critical platform provides secure remote access to participant medical records and study source documents, ensuring compliance and preventing delays in regulatory submissions to the FDA and EMA. The procurement includes all necessary software subscriptions, licenses, hosting, maintenance, updates, and technical support to ensure uninterrupted functionality for government users and clinical trial stakeholders. The contract is planned for a one-year base period of performance with two additional one-year options. It will be awarded on a non-competitive sole source basis to Medidata Solutions, Inc., as they are the original software publisher and do not permit third-party hosting. The applicable NAICS code is 513210 for Software Publishers, with a small business size standard of 47 million dollars. While this is a sole source intent, responsible sources may submit detailed capability statements to the Office of Mission Acquisition Solutions by 3:00 PM EST on September 29, 2026. All potential awardees must maintain valid registration and certification through SAM.gov.

General Info

NIH sole source contract with Medidata Solutions for clinical trial monitoring SaaS software.

Agency

Department Of Health And Human Services → Omas Strategic Buying Center - Information Technology

NAICS

513210 - Software Publishers

Place of Performance

Rockville, MD, USA

Set-Aside

NONE

Documents

2 pages · presolicitation

Low

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedSep 21

Presolicitation

Response DeadlineSep 29

Deadline has passed

Submission Closed

09/29/2026, 08:00:00 PM EDT

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → Omas Strategic Buying Center - Information Technology

Contacts1 person available

OfficeRockville, MD, 20857, USA

Organization / AgencyDepartment Of Health And Human Services → Omas Strategic Buying Center - Information Technology

Office AddressRockville, MD, 20857, USA

Contacts

Christopher Shih

contact@example.gov

Full 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 contact@example.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.