Operations, Maintenance, and Modernization Support for ClinicalTrials. gov

Awarded Limited / Sole Source Justification Posted

Solicitation number
75N97023Q00086
Agency
National Institute of Environmental Health Sciences National Institutes of Health, Department of Health and Human Services
Set-aside
No set-aside

Opportunity facts

Contract number
GS-00F-010CA-75N97023F00106 Federal contract award
NAICS code
541511 Custom Computer Programming Services
PSC
R499 Support- Professional: Other
Place of performance
United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Health and Human Services National Institutes of Health (NIH) National Library of Medicine has issued a Limited Source Justification for operations, maintenance, and modernization support of ClinicalTrials.gov, awarding a contract to ICF Incorporated for an estimated $8,132,837. The six-month contract extension, running from March 27, 2025 to September 26, 2025, is being awarded sole-source due to ICF's unique expertise in the ongoing modernization of the clinical trials registration system. The platform, which hosts over 525,000 registered clinical studies and serves over 200,000 daily users, requires specialized continuous support to maintain its critical research infrastructure. Replacing the contractor would introduce significant risks, including potential service disruptions and delays in modernization efforts. The justification emphasizes ICF's critical institutional knowledge from leading the system's modernization since 2021, with the contract period designed to allow NIH to complete infrastructure upgrades and prepare for a future competitive procurement while ensuring uninterrupted service of this Congressionally mandated platform.

Notice text

The purpose of this requirement is for the acquisition of operations, maintenance, and modernization of ClinicalTrials.gov. Services include complex professional specialized expertise, some of which is Information Technology (IT) services. NLM is responsible for the legislatively mandated ClinicalTrials.gov information resource which, in part, is supported by this effort.

The objective of this effort is to establish a new task order to ensure continuity of mission critical services and support diverse tasks aligned with new and expanding Congressional mandates, changing policies and information technologies, expanding NIH research programs, and NLM's role in the NIH community until the modernization of the ClinicalTrials.gov is complete.

Awarded contract GS-00F-010CA to unknown vendor for unknown amount on 2023-09-28.

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