Research Excellence That Advances Medicine and Improves Lives
The DCRI combines the clinical expertise of practicing physicians with the full-service operational capabilities of a clinical research organization (CRO). We also have the unique advantage of being embedded within Duke University's world-class academic medical center infrastructure. With decades of specialized experience executing complex clinical trials of all phases and sizes, we deliver accelerated study startup timelines, exceptional data quality, and regulatory-compliant results that transform healthcare for patients everywhere.
Comprehensive Clinical Trial Capabilities
Our experienced teams deploy nimble and responsive operational approaches, designing clinical trials rooted in real-world patient needs across all study phases. We're not bound by traditional study frameworks. Instead, we collaborate with sponsors to design the optimal approach for each therapy, indication, and regulatory pathway, offering innovative strategies that combine proven methodologies with scientific rigor to reduce risk, accelerate enrollment, and maximize success while maintaining the highest standards.
From Phase I-IV & Beyond
Coordinated through the DCRI in partnership with the Duke Early Phase Research Unit (DEPRU), providing first-in-human studies with a comprehensive safety infrastructure and innovative approaches to early-stage drug development.
Our core expertise in designing and executing registration-enabling studies for pharmaceutical and biotech drug development programs with efficient timelines and reliable data quality supports regulatory submissions.
Real-world evidence generation and safety surveillance that extends beyond regulatory approval to understand long-term treatment effects and optimize clinical practice, and continually improve patient outcomes.
Specialized expertise in medical device research across all phases, with unique capabilities in cardiovascular, orthopedic, and digital health technologies.
Research-to-practice expertise that accelerates the adoption of evidence-based interventions in real-world healthcare settings, ensuring therapies, processes, and engagement strategies translate into improved patient care across federal and private healthcare systems.
Adaptive Study Design
We integrate real-world clinical care components when patient engagement and enrollment acceleration are priorities, streamlining processes while maintaining regulatory compliance and data quality standards.
Our virtual and hybrid capabilities expand geographic reach and enhance patient convenience when traditional site-based approaches present barriers, utilizing digital technologies to maintain oversight and data integrity.
We design classic randomized controlled trials when regulatory pathways demand traditional structure, leveraging decades of experience in complex protocol development and regulatory submission support.
DCRI’s real-world evidence generation and registry management capabilities inform clinical practice and support regulatory submissions through comprehensive data collection and analysis
Our teams excel at combining multiple methodological approaches within single studies, creating customized solutions that optimize outcomes for specific therapeutic areas, patient populations, and regulatory requirements.
Integrated Services
Planning & Start-Up
- Study and program design optimized for efficiency
- Site feasibility, selection, and training
- IRB submissions and regulatory coordination
Recruitment & Retention
- Electronic medical record-based pre-screening for faster patient identification
- Centralized call center and patient engagement solutions
- Website-based recruitment aids and digital patient portals
Study Execution
- Expert clinical trial management with proactive communication
- Site, medical, and safety monitoring
- Pharmacovigilance and comprehensive vendor management
Data & Dissemination
- Full-service electronic data capture and database services
- Biostatistics, programming, and regulatory-compliant data analysis
- Medical writing and regulatory submissions
- Implementation design and post-approval research execution
Specialized Trial Support Services
Advanced Analytics & Data Science: Statistical faculty and operational statistics teams provide pharmaceutical sponsors with FDA-ready data analysis and innovative evidence strategies
Digital Health Solutions: Drawing on cutting-edge technological expertise to validate, implement, and optimize digital health solutions
Efficacy & Safety Services (CSI+): A cross-functional approach to core trial medical requirements, ensuring comprehensive and efficient performance across event adjudication, safety surveillance, pharmacovigilance, and specialized core labs (imaging, arrhythmia, and hemodynamics).
Health Services Research: Patient-centered research initiatives that evaluate care delivery, outcomes, patient preferences, and health policy to improve practice and inform healthcare decision-making
Research Communications & Engagement: Strategic participant recruitment, engagement, and retention solutions that improve study completion rates
Why Sponsors Trust the DCRI
- Accelerated Timelines: Decades of specialized experience reducing study startup times compared to traditional CROs through our academic medical center infrastructure and established site relationships, delivering efficient solutions that keep drug development programs on schedule.
- Scientific Leadership: Research led by practicing physicians who implement trials grounded in the realities of clinical care, ensuring studies answer questions that matter to patients and regulatory authorities with innovative approaches to complex challenges.
- Operational Excellence: Over 700 operational employees support every phase of clinical trial management, employing a proactive approach that manages complexity and drives engagement, ensuring reliable execution across all study types.
- Regulatory Success: Proven track record with 3,675+ FDA submissions since 2008, demonstrating our ability to generate regulatory-compliant data that supports successful approvals through reliable processes and scientific rigor.
Our Clinical Research Areas
Across our global network, our physician-scientists provide deep expertise across multiple therapeutic areas critical to pharmaceutical and biotech development, with research conducted by specialists who treat patients with the same conditions every day:
Cardiovascular, Renal & Metabolic | Gastroenterology | Infectious Diseases | Musculoskeletal | Neurosciences | Pediatrics | Respiratory Medicine
Each therapeutic area is supported by practicing clinicians who understand the unique challenges of developing treatments in their specialty, ensuring that study designs are optimized for regulatory success and that development pathways are clearly understood.
Global Site Network & Strategic Partnerships
Our trusted network spans over 1,100 research sites across the United States, as well as established partnerships in more than 40 countries worldwide. This includes academic medical centers, community-based practices, and specialized research sites, with selection tailored to specific disease areas and study requirements.
Through strategic CRO partnerships, we offer flexible options for conducting studies worldwide while maintaining our high standards for site management, data quality, and regulatory compliance.
