Duke Clinical Research institute

What Duke Clinical Research institute does

Duke Clinical Research Institute (DCRI) is the world's largest full-service, mission-driven academic clinical research organization, operating as a non-profit institute within Duke University School of Medicine. Headquartered in Durham, North Carolina, DCRI runs Phase II-IV clinical trials and observational studies for pharmaceutical, biotechnology, and medical device sponsors, alongside government-funded comparative effectiveness and pragmatic research. The organization employs 1,001-5,000 staff and faculty, supports 400+ ongoing studies, and has cumulatively enrolled more than 2 million patients across 2,500+ completed Phase I-IV studies, contributing to 3,675+ FDA submissions over its 30-year history.

DCRI's core offerings span end-to-end clinical trial execution, biostatistics and data management (including the SOAR DATA, O2E, and ORBIT programs), digital health solutions, efficacy and safety assessment via the CSI+ platform, health services research and real-world data analysis, implementation science, and innovation services through the i-Cubed center. Its technology stack combines practicing-physician insights from Duke Health with proprietary AI capabilities — most notably ADAPT-CEC, a hybrid AI for clinical event adjudication — and external AI-agent platforms via Health Universe that compress trial setup timelines by 30-40x. The Research Together program and DCRI Think Tanks institutionalize patient engagement and multi-stakeholder convening as core operational competencies.

DCRI generates revenue through three principal streams: industry-sponsored clinical trials (Amgen, Boehringer Ingelheim/Eli Lilly, Milestone Pharmaceuticals, Shinkei Therapeutics, and others), government-funded research from NIH and PCORI, and strategic collaborations with large CROs (notably IQVIA for obesity and cardiometabolic programs). Pricing is study-by-study under contract research arrangements with no public tiers. Notable recent engagements include the Amgen Tavneos independent re-adjudication contract and the multi-stakeholder Precision Health Alliance consortium with leading gene editing sponsors.

Name

Duke Clinical Research institute

Legal name

Duke Clinical Research Institute

Website

https://dcri.org

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

DCRI is the world's largest full-service academic clinical research organization, part of Duke University School of Medicine, conducting Phase II-IV trials, real-world evidence research, and AI-enabled study execution for pharmaceutical, biotech, and government sponsors.

Ownership category

akta.pro rank

Product category

Clinical Research Services

NAICS

Scientific Research and Development Services (5417), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Decentralized/Hybrid Trial Enablement (DCT) Platforms (HLACAOAL), Clinical Research & Trial Central Laboratories (HLAFAMAL)

Keywords

• Clinical trial services
• Academic research organization
• Clinical data analytics
• Pharmaceutical research services
• Real-world evidence research

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others

Revenue model

1. Government-Funded Research: DCRI conducts NIH-funded clinical trials and receives PCORI (Patient-Centered Outcomes Research Institute) grants for comparative effectiveness research. Examples include PCORI-funded autism research ($12.9M award) and PCORI-funded palliative care trials.
2. Industry-Sponsored Clinical Trials: DCRI serves as a full-service CRO executing Phase II-IV clinical trials for pharmaceutical, biotech, and medical device companies. Examples include Amgen's Tavneos re-evaluation, Shinkei Therapeutics' TBI trial, Milestone Pharmaceuticals' CARDAMYST registry, Boehringer Ingelheim and Eli Lilly-funded COORDINATE-Diabetes study.
3. Strategic Collaborations and Partnerships: Formal collaborations with industry partners (e.g., IQVIA obesity and cardiometabolic trials) that combine DCRI's academic rigor and site infrastructure with partner operational capabilities, generating revenue through study execution and consulting.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels8 records

Core offering

DCRI conducts Phase II-IV clinical trials as a full-service academic CRO for pharmaceutical, biotech, and medical device sponsors. It also delivers biostatistics and data science, clinical event adjudication (CSI+), real-world evidence and outcomes research, digital health solutions, and implementation science services that translate evidence into clinical practice.

Product overview

Duke Clinical Research Institute (DCRI) is the world's largest full-service, mission-driven academic clinical research organization, operating as a single integrated platform that combines insights from practicing physicians in a world-class health system with data science expertise and end-to-end operations infrastructure. The organization offers a comprehensive suite of research services organized into distinct solution areas: Clinical Trials Execution for Phase II-IV studies; Analytics and Data Science for biostatistics and data management; Digital Health Solutions for technology-enabled research; Efficacy & Safety (CSI+) for clinical event classification; Health Services Research and Outcomes for real-world evidence; i-Cubed: DCRI Innovation Center for developing new clinical research tools; Implementation Science for translating evidence into practice; Research Communications & Engagement for strategic communication; Partner Engagement through the Research Together program; and DCRI Think Tanks as a convening platform for multi-stakeholder collaboration.

Differentiator

Problem solved

Functional benefit

Brands

• i-Cubed: DCRI's center for clinical research innovation supporting individuals, teams, and organizations in turning ideas into tools, technologies, and processes that transform clinical research.
• Research Together™
• Precision Health Alliance
• DCRI Think Tanks

Products and services

• Clinical Trials Execution End-to-end clinical research services including study design, protocol development, site feasibility, regulatory submissions, project management, pharmacovigilance, biostatistics, and medical writing for Phase II-IV trials. For pharmaceutical, biotech, and medical device sponsors.
• Analytics and Data Science Expert biostatistics, data management, and analytics services including SOAR DATA for data sharing, O2E program for outcomes and estimands, and ORBIT interdisciplinary hub. For clinical trial sponsors and researchers.
• Digital Health Solutions Digital health technology solutions enabling remote monitoring, telehealth integration, and technology-enabled clinical research delivery. For sponsors and clinical research teams.
• Efficacy & Safety: CSI+ Comprehensive efficacy and safety assessment services including clinical event classification, imaging, arrhythmia, pulmonary, and hemodynamic core capabilities. For sponsors requiring rigorous endpoint adjudication and core lab services.
• Health Services Research and Outcomes Health services research, real-world data analysis, evidence synthesis, registries, and preference evaluation research to generate evidence for clinical practice improvement. For sponsors and research collaborators.
• i-Cubed: DCRI Innovation Center Innovation center supporting development of new tools, technologies, and processes to transform clinical research, offering consultation, mentorship, and support to startup innovators and industry partners in biopharma and health technology.
• Implementation Science Evidence-based implementation strategies, knowledge dissemination, and stakeholder engagement to accelerate translation of research findings into clinical practice across healthcare systems. For health systems, payers, and research funders.
• Research Communications & Engagement Strategic communication and engagement services including planning and design, recruitment and retention campaigns, digital and social media, publication support, and plain language summaries. For sponsors and research collaborators.
• Partner Engagement Patient and site engagement program integrating lived experience into research design, conduct, oversight, and dissemination through the Research Together framework. For sponsors and research networks.
• DCRI Think Tanks Multi-stakeholder convening platform bringing together academia, industry, government, and community to address key issues in clinical research design, conduct, and implementation through annual summits and working groups. For healthcare leaders shaping clinical research agendas.

Quantifiable outcome

• COORDINATE-Diabetes trial showed 23.4% absolute difference in prescription of all three evidence-based therapies between intervention and standard care groups for Type 2 diabetes with ASCVD patients.
• +4 more outcomes

Named customers9 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core and notable.

• AmgencoreStrategic or Co-development Partner · 30 June 2026Amgen engaged DCRI to independently re-adjudicate clinical trial data from the ADVOCATE trial for Tavneos (avacopan) following FDA concerns about data manipulation by the original developer ChemoCentryx. DCRI was commissioned to perform an independent data re-analysis as part of Amgen's defense against the FDA's proposal to withdraw Tavneos' approval, with results submitted by June 29 as part of Amgen's formal response.
• Health UniversenotableTechnology or Integration · 18 May 2026Health Universe partnered with DCRI to deploy autonomous AI agents that automate documentation, streamline regulatory workflows, and reduce clinical trial setup time from 9 months to approximately 7.5 days. The partnership enables research teams to run flexible workflows over data rather than simply transcribing conversations, with early results showing 93% time savings across key workflow tasks and 30-40x acceleration in trial setup timelines.
• Precision Health Alliance (coordinated by DCRI)coreStrategic or Co-development Partner · 14 April 2026The Precision Health Alliance is a consortium coordinated by DCRI to develop ethical and regulatory frameworks for gene editing and precision medicine. Supported by AskBio/Bayer, BEAM Therapeutics, CRISPR Therapeutics, and Intellia Therapeutics. The alliance engages patients, clinicians, health systems, regulatory experts, and bioethicists to ensure patient-centered, safe, and ethical gene therapy development.
• Milestone PharmaceuticalsnotableStrategic or Co-development Partner · 10 April 2026DCRI leads the RESET-PSVT registry for Milestone Pharmaceuticals' CARDAMYST (etripamil) nasal spray, a planned Phase 4 multicenter registry expected to enroll approximately 450 adult patients across 20 electrophysiology and cardiology sites to generate real-world evidence in paroxysmal supraventricular tachycardia.
• Shinkei TherapeuticsnotableStrategic or Co-development Partner · 9 March 2026DCRI collaborated with Shinkei Therapeutics to conduct the Phase 2 SHINKEITBI trial evaluating MR-301 IV Solution in patients with severe traumatic brain injury across multiple U.S. sites. DCRI's operational infrastructure supported site management and trial execution for this acute neurological condition study.
• IQVIA HoldingscoreStrategic or Co-development Partner · 10 February 2026IQVIA and DCRI announced a strategic collaboration to enhance clinical research in obesity and related cardiometabolic conditions. The partnership combines IQVIA's operational excellence and global reach with DCRI's academic rigor and trial infrastructure, expanding access to diverse patient populations across 56 countries and more than 3,000 sites. IQVIA has supported every FDA-approved GLP-1 therapy through over 120 obesity trials and 90,000 enrolled patients.
• i-Cubed Innovation Center PartnersnotableStrategic or Co-development Partneri-Cubed, DCRI's center for clinical research innovation, partners with industry innovators in biopharma and health technology spaces to refine and test groundbreaking ideas through its 'Partner Innovations' path. Services include consultation, mentorship, and support to advance new products and initiatives.
• CardioVascular Clinical Trialists (CVCT)coreStrategic or Co-development PartnerDCRI and CVCT announced a formal three-year partnership titled 'Pathway to Prevention' to establish clear pathways to regulatory and clinical acceptance of cardiovascular prevention therapies. The initiative unites stakeholders from academia, industry, government, nonprofits, and technology sectors to develop practical guidance advancing prevention indications.
• Gateway for Cancer ResearchnotableStrategic or Co-development PartnerGateway for Cancer Research funded a Duke Cancer Institute clinical trial testing a combination of immunotherapy drugs (Botensilimab and Balstilimab) for metastatic colorectal cancer, led by Dr. Nicholas DeVito with DCRI involvement.
• Antibacterial Resistance Leadership Group (ARLG)notableStrategic or Co-development PartnerThe ARLG, based at DCRI, was prominently featured at ESCMID Global Congress 2026 with two multicenter studies selected for special late-breaking sessions, focusing on antibiotic resistance research.
• CardioHealth AlliancenotableStrategic or Co-development PartnerCardioHealth Alliance was formed by leading cardiologists at Stanford and Duke Universities in 2019 to engage clinicians, data scientists, healthcare leaders, life science partners, and policymakers to improve care across cardiovascular, renal, and metabolic diseases. DCRI implementation science experts guide the Alliance's work using real-world data.
• PCORnet (National Patient-Centered Outcomes Research Network)notableStrategic or Co-development PartnerDCRI serves as operational lead for PCORnet, a national network supporting pragmatic research designs and real-world data utilization for patient-centered outcomes research.

Scale indicators11 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• IQVIA Holdings: IQVIA is the world's largest commercial CRO and a direct DCRI partner. It operates across all clinical trial phases with global site networks, biostatistics, and real-world evidence capabilities — directly comparable to DCRI's full-service academic CRO model, with broader commercial scale.
• Labcorp (Drug Development & Central Labs): Labcorp Drug Development (formerly Covance) provides global CRO services plus a major central laboratory network. Directly comparable to DCRI's clinical trial execution and CSI+ central lab capabilities, with additional commercial diagnostics infrastructure.
• PPD (Thermo Fisher Scientific): PPD, acquired by Thermo Fisher, is a top-tier global CRO offering comprehensive clinical development and laboratory services. Comparable across full-service CRO capabilities including central labs, biostatistics, and regulatory affairs.
• Charles River Laboratories: Charles River provides preclinical and clinical CRO services plus manufacturing and central lab capabilities. Comparable to DCRI's CSI+ central lab and clinical trial execution services, with additional discovery and manufacturing infrastructure.

Direct peers

• ICON plc: ICON is one of the largest global CROs offering Phase I-IV clinical trial services, biostatistics, and post-approval research. Following the PRA Health Sciences acquisition, it competes directly with DCRI for industry-sponsored trials across cardiovascular and other therapeutic areas.
• Parexel International: Parexel is a major global CRO offering Phase II-IV clinical trial services, regulatory consulting, and biostatistics. It is a directly comparable commercial peer competing for the same biopharma sponsors that engage DCRI.
• Medpace: Medpace is a mid-to-large global CRO specializing in Phase II-IV clinical trials across multiple therapeutic areas including cardiovascular and oncology. Directly comparable to DCRI in industry-sponsored Phase II-IV execution with strong operational reputation.
• Syneos Health: Syneos Health is a fully integrated biopharmaceutical solutions organization offering CRO and commercial services. It competes with DCRI for industry-sponsored trials across therapeutic areas with similar end-to-end clinical development offerings.
• Clinical Trial Service Unit (CTSU), University of Oxford: CTSU at Oxford is one of the few other world-class academic CROs conducting large-scale randomized clinical trials and epidemiological studies. Directly comparable to DCRI as a mission-driven academic research organization with deep biostatistics and trial coordination capabilities.

Emerging players

• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized global CRO focused on Phase II-IV trials across neuroscience, cardiovascular, and rare diseases. Compares to DCRI's therapeutic-area specialization and mid-scale full-service CRO positioning.

Market position

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/DCRINews
• YouTubeyoutube.com/channel/UCm8DRqjkykFsX941iJFSSig
• LinkedInlinkedin.com/company/duke-clinical-research-institute
• Facebookfacebook.com/DukeClinicalResearchInstitute

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Duke Clinical Research institute