Regenstrief Institute Inc.

Regenstrief Institute Inc., a 501(c)(3) non-profit research organization headquartered in Indianapolis, Indiana, operates as both a prime contractor and grant recipient on federal health informatics, clinical data management, and biomedical research support work, competing without SBA certifications in full-and-open procurements. Established in 1969 and closely affiliated with Indiana University School of Medicine, IU Health, and Eskenazi Health, Regenstrief delivers health information technology platforms, data standardization and interoperability services, and clinical research infrastructure to federal health agencies across contracts and grants.

The National Institutes of Health dominates Regenstrief's customer base, accounting for 46 percent of recent awards across five institutes and centers. The National Institute on Aging leads by count with 22 awards; the National Center for Advancing Translational Sciences anchors dollar value with 10 awards worth $20.8 million combined potential value; and the National Library of Medicine, National Institute of Environmental Health Sciences, and National Institute of Diabetes and Digestive and Kidney Diseases round out the active set. By potential value, the top five customers (NIH NCATS, NIHS, NLM, CMS, and GSA) account for 74 percent of the combined $83.1 million in total awards. The agency concentration reflects Regenstrief's mission-fit in health data research rather than dispersed federal sales across many agencies.

Regenstrief's capability portfolio centers on LOINC (Logical Observation Identifiers Names and Codes) terminology maintenance and standardization, secure data enclave and honest broker services for multi-site patient cohorts, health informatics systems engineering, electronic health record (EHR) data extraction and natural language processing, and clinical research data management. Representative prime contracts include a $5 million firm fixed-price purchase order with the National Library of Medicine for LOINC services through June 2029 (awarded June 2024, sole-source under FAR 6.302-1); a $2.13 million definitive contract with the Centers for Medicare and Medicaid Services for post-acute care assessment data services under the IMPACT Act through September 2031 (awarded September 2026); and a $4.75 million delivery order with the National Institutes of Health for N3C Linkage Honest Broker software and technical services under a $15 million NCATS indefinite delivery contract through September 2027 (awarded September 2026). Regenstrief also operates the National COVID Cohort Collaborative (N3C) Data Enclave, a secure research platform providing de-identified patient data for authorized researchers, with prior delivery orders ranging from $1.27 million to $5.11 million across FY2022–FY2026.

Regenstrief operates as a prime on 41 awards (38 percent) and as a subcontractor or grant sub-recipient on 66 awards (62 percent), indicating a mixed posture leaning toward sub-engagement and grant sub-award participation. Across SCI-reportable prime service contracts, subcontractors account for 7 percent of total contractor hours on average, and 14 named subcontractors appear in the SCI dataset, suggesting Regenstrief builds most delivery teams internally rather than relying on deep supply chains. In its sub role, Regenstrief supplies data services, project management, and biomedical informatics expertise to university prime grantees—notably the Trustees of Indiana University, Purdue University, the University of Pennsylvania, and Mayo Clinic Jacksonville—on NIH-funded research projects spanning Alzheimer's disease, diabetes surveillance, post-COVID-19 outcomes, pediatric kidney transplant logistics, and clinical trial simulation. Sub-award activity has grown sharply: eight sub-awards in 2024 and 18 in 2025 (through September), with 2024–2025 sub-awards including work on Alzheimer's clinical eligibility criteria design (Weill Medical College of Cornell), diabetes risk prediction (Trustees of Indiana University), and BSSR data harmonization for Alzheimer's research (Mayo Clinic Jacksonville).

SCI-reported invoiced revenue on Regenstrief's prime service contracts totaled $5.7 million in FY2022, $5.8 million in FY2023, and $5.3 million in FY2024, with FTE workforce scaled around 11–12.5 FTEs on SCI-reportable contracts in those years. On SCI-captured work, government-paid hourly rates median around $221.25/hr, ranging from a 10th percentile of $123.30/hr to a 90th percentile of $569.39/hr, reflecting a mix of project management, senior technical analysis, and senior subject-matter expertise. Regenstrief's active GSA Multiple Award Schedule portfolio carries 18 labor categories priced from $62.10/hr (Project Admin, associate degree, no clearance) through $323.72/hr (Subject Matter Expert with PhD), with no security-cleared roles offered. Five task orders under the GSA MAS carry combined potential value of $15.4 million.

Activity accelerated significantly: two awards in 2022 to 32 in 2024, with 19 awards in 2025 through September and 14 in 2026 through September. Only one award faces ultimate completion within the next twenty-four months, carrying combined potential value of $4.8 million, so recompete exposure in the near term is minimal. The source's award distribution across 34 distinct customer agencies and the concentration of sub-award work under university-led NIH grants suggest Regenstrief functions as a specialized health informatics and clinical data services partner rather than a broad federal IT contractor, with competitive positioning anchored to NIH's translational science and clinical research infrastructure priorities.