NOI - Medidata RSR FY27.pdf

SOLE SOURCE - NOTICE OF INTENT

Title: Medidata Remote Source Review (RSR) Solicitation/Reference Number: HHS-OMAS-2027-03 Posted Date: September 21, 2026 Response Date: September 29, 2026 PSC Code: DA10 - IT and Telecom - Business Application/Application Development Software as a Service (SaaS) NAICS Code: 513210 Software Publishers

1.0 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.

2.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

Medidata Solutions, Inc. is the incumbent contractor for Medidata Remote Source Review supporting NIAID under Contract No. 75N93026P00007, which expires December 31, 2026.

They are the original publishers of the software and do not allow external parties to host their software.

Medidata Remote Source Review (RSR) is a mission-critical platform that provides secure, compliant remote access to participant medical records and study source documents for clinical trial monitoring. The platform supports source document review and source data verification in a secure environment and is essential to maintaining continuous oversight of clinical trial activities. Any interruption in access to Medidata RSR could create monitoring gaps, delay identification and escalation of adverse events and other safety signals, compromise participant safety, affect data accuracy and integrity, disrupt trial timelines, and delay regulatory submissions to agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)

Transitioning to an alternative software package within the required timeframe would pose risks, including potential data loss, service downtime, and disruption to mission-critical research and operational workflows. Any alternative software package will also require training of all authorized Government users and designated clinical trial stakeholders.

3.0 RESPONSE INSTRUCTIONS

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.

mailto:christopher.shih@hhs.gov