NHLBI Clinical Data Management Support Services
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Heart, Lung, and Blood Institute (NHLBI), under the Department of Health and Human Services, has issued a Sources Sought Notice for Clinical Data Management Support Services. This market research aims to identify qualified small businesses capable of providing comprehensive data management for NHLBI's Division of Intramural Research (DIR) clinical programs in Bethesda, MD. Capability statements are due June 15, 2026.
Scope of Work
The primary objective is to provide comprehensive data management support to the DIR clinical research program. This includes:
- Clinical Data Managers (CDMs): Employing 20 full-time CDMs to support DIR's clinical research teams. CDMs will handle research data-related activities (data entry, process development, adverse event abstraction, reporting, audit preparation, discrepancy reconciliation, monitoring assistance).
- Quality Assurance/Quality Control: Performing QA/QC activities, including a three-step QC process (Self, Peer, Supervisor) and ensuring timely data reporting.
- CIBMTR Data Management: Managing data for transplant-related protocols, including collection, reconciliation, entry, and submission to the Center for International Blood & Marrow Transplant Research (CIBMTR).
- Database-related Activities: Data entry into protocol-specific databases, assisting with eCRF development, and supporting clinical databases.
- Contract-level Management: Providing personnel management (supervision, training, performance monitoring, retention), reporting to the Office of the Clinical Director (OCD), hiring and onboarding staff (30-day fill time for vacancies), managing Standard Operating Procedures (SOPs), and executing phase-in (30 days) and phase-out services (90 days prior to expiration). A communication plan is also required.
Contract & Timeline
- Type: Sources Sought (Market Research)
- NAICS Code: 541990 – All Other Professional, Scientific, and Technical Services
- Anticipated Period of Performance: One base year and four option years, totaling five years.
- Published Date: June 5, 2026
- Response Due: June 15, 2026, by 3:00 p.m. EST
Submission Requirements
Interested small businesses must submit capability statements addressing each project requirement. Submissions should include: total number of employees, professional qualifications of technical personnel, description of facilities and equipment, outline of similar previous projects, and any other relevant information. Statements must not exceed 15 single-sided or 7.5 double-sided pages, using a 12-point font minimum. No proprietary or confidential data should be submitted.
Eligibility / Set-Aside
This notice is specifically for small businesses. Organizations must identify their size standards under NAICS code 541990. Only small businesses under this NAICS code should respond.
Additional Notes
This is NOT a request for proposals and does not commit the Government to award a contract. The information gathered will assist in determining the appropriate acquisition method. Submissions should be sent via email to John Lear (john.lear@nih.gov), referencing Sources Sought Notice number 75N98026Q00536 in the subject line.