Description
The National Heart, Lung, and Blood Institute (NHLBI) is seeking small‑business capability statements to support the CureSCi Long‑Term Follow‑Up (LTFU) Consortium Coordinating Center and its Natural History Data Resource (NHDR). The contractor will manage multi‑center clinical study operations, longitudinal data and biospecimen collection, data management, reporting, metadata catalog support, participant engagement, and ancillary‑study assistance for a ten‑year period. The effort supports the WARRIOR‑SCD study and broader CureSCi program goals, requiring expertise in clinical research coordination, informatics, statistics, and regulatory compliance. One award is anticipated around April 2028, with a ten‑year performance window.
• Provide full‑time program management and staff to operate the Coordinating Center.
• Maintain and expand the NHDR, including clinical data, PROs, biospecimen handling, and quality‑control processes.
• Coordinate with NHLBI, participating sites, and external subcontractors.
• Deliver data‑strategy, meeting, website, and metadata‑catalog services.
• Support participant retention, community engagement, and educational material development.
• Enable ancillary, investigator‑initiated studies using NHDR resources.
• Ensure compliance with all federal, NIH, and NHLBI data‑privacy and security requirements.