Clinical Research Operations and Management Support (CROMS)
Closed Solicitation Posted
- Solicitation number
- 75N92025R00010
- Agency
- National Heart Lung and Blood Institute National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
-
- Knox, Tara C. knoxt@nhlbi.nih.gov (301) 827-7551
- Natalie E Bruning natalie.bruning@nih.gov (301) 827-7528
Notice details come from SAM.gov. Updated .
About this opportunity
The National Heart, Lung and Blood Institute (NHLBI) is seeking a contractor to provide comprehensive Clinical Research Operations and Management Support (CROMS) for the National Institute of Dental and Craniofacial Research (NIDCR). The solicitation seeks a contractor to deliver clinical research management, oversight, and operational support including clinical study documentation, site monitoring, data management, statistical support, and regulatory compliance. Proposals are due by February 10, 2025, with questions accepted until January 3, 2025. The evaluation will prioritize technical approach (40 points), followed by cost and past performance (30 points each). Key requirements include maintaining strict security and privacy controls, obtaining appropriate staff clearances, and adhering to HHS/NIH information system and data protection policies.
The contract is set aside for small businesses under NAICS code 541715 with a size standard of $1,000. The current incumbent is Rho Federal Systems, Inc., and the contract will be a cost-reimbursement and firm fixed-price type. The base period runs from September 30, 2025, through September 29, 2026, with four potential one-year option periods extending through September 29, 2030. Performance will be located in Bethesda, MD 20892. The contractor will be responsible for supporting clinical research through the existing NIDCR Clinical Research Management System (CRMS), providing services such as FDA regulatory support, safety reporting, statistical analysis, and data/safety monitoring committee support. While specific budget details are not disclosed, the contract represents a significant multi-year commitment to advancing clinical research infrastructure.
Notice text
2 versions
Update #2 · Latest ·
Attachment 1: Solicitation
Attachment 2: Amendment 1
Update #1 ·
See attached Solicitation for full details.
Attachments
| File | Type | Posted |
|---|---|---|
| 75N92025R00010_Amendment_1.pdf | ||
| Sol_75N92025R00010 w_attachments.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Clinical Research Operations and Management Support (CROMS) | Solicitation | |
| Clinical Research Operations and Management (CROMS) | Pre-Solicitation | |
| Clinical Research Operations and Management (CROMS) | Special Notice |
On GovTribe
Work this opportunity on GovTribe
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity