NIH/NLM/NCBI Sole Source Justification for Operation/Maintenance/IT Support ClinicalTrials. Gov

Awarded Limited / Sole Source Justification Posted

Solicitation number
PCA-NLM-03137
Agency
Set-aside
No set-aside

Opportunity facts

Contract number
47QTCA18D00JA-75N98026F00322 Federal contract award
NAICS code
Not on record
Place of performance
Bethesda, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institutes of Health, through the National Library of Medicine, has awarded a sole-source bridge task order to Black Canyon Consulting, LLC under GSA Schedule contract 47QTCA18D00JA for operations, maintenance, and IT support of ClinicalTrials.gov, with a value of $15,017,534 for the 12-month period August 27, 2026 through August 26, 2027.

The justification rests on preventing service lapse when the incumbent's current task order 75N98022D00019/75N98025F00008 expires on August 26, 2026. Market research identified only four vendors capable of providing the specialized clinical trials expertise required to manage over 595,000 registered clinical studies and process 850–1,200 new studies weekly while supporting FDA regulatory requirements under the Food and Drug Administration Modernization Act and FDA Amendments Act. The award is justified as a logical follow-on under GSAM/R 538.7104-3(b)(1)(iii) in the interest of economy and efficiency, as transitioning to a new vendor would create unmitigated risks to program operations, delay clinical trial publications mandated by FDA, and duplicate transition costs. The bridge award is funded using fiscal year 2026 appropriated funds. NIH plans to conduct a broader competitive procurement through a multi-award Blanket Purchase Agreement, with a Sources Sought notice to be posted December 4, 2026, an Acquisition Plan finalized by March 1, 2027, and an RFP posted by March 8, 2027, with intended award by May 25, 2027.

Notice text

Operations, Maintenance, and IT Support for ClinicalTrials.gov Porgram Management Support 

Awarded contract 47QTCA18D00JA to unknown vendor for unknown amount on 2026-08-26.

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