DEPRU Clinical Research Unit

We leverage the unique capabilities of an academic medical center, adaptive design methodologies, and access to specialized services and populations to conduct a variety of studies with industry and government partners.

Studies Conducted at DEPRU

We leverage the unique strengths of an academic medical center, adaptive design methodologies, and access to specialized services and populations to conduct a wide range of studies.

Standard Services

  • Phase 1: First-in-Human Trials
  • Healthy Volunteers
  • Escalating Dose Studies (SAD/MAD)
  • Bioavailability/Bioequivalence
  • Drug-Drug Interaction and Food Effect Studies

Specialized Services

  • Phase 0 Studies
  • Hybrid and Special Populations
  • Invasive Procedures and Monitoring
  • Innovative PD Endpoints and Adaptive Design
  • Device and Technology Validation
  • Imaging, Endotoxin, Sleep Studies, and More

Our integrated expertise ensures efficient execution, robust data collection, and high-quality outcomes for even the most complex early-phase trials.

Accelerated Enrollment via Targeted Recruitment

handsDuke Health Research Volunteer Registry

  • Over 7,600+ consented volunteers and growing
  • Includes:
    • 4,076 registered healthy volunteers
    • 3,588 volunteers with medical conditions

D.E.D.U.C.E.An icon of a person sitting with a laptop, which displays coding brackets (<>), representing a programmer or developer.

  • EHR (Electronic Health Record) query system
  • Identifies patient populations using ICD codes
  • Facilitates automated patient messaging

Traditional MethodsAn icon of a person at the center with five connected lines extending outward. Each line ends in a circle containing symbols: hearts, thumbs-up, and a plus sign, representing social connections, likes, and positive interactions.

  • Advertisements (social media, letters)
  • Patient referrals
  • Phone outreach conducted by expert recruiters

D.I.S.C.E.R.N.An icon of a blue emergency siren light with lines radiating outward, indicating an alert, warning, or urgent situation.

  • Identifies eligible subjects on arrival to the health system
  • Alerts study personnel for streamlined enrollment

Experience by Numbers (Average Per Year)

With an impressive track record, we deliver unmatched expertise and efficiency in clinical research:

  • 33 active studies spanning 21 diverse therapeutic areas annually.An icon showing three people standing together behind an upward trending arrow, symbolizing teamwork, growth, and progress.
  • 7,500+ registry volunteers, with 53% being healthy participants.
  • 5 audits per year (71 total since inception).
  • 1,800 outpatient visits on average annually.
  • 300+ confinement visits conducted annually.
  • 7,000+ biospecimens processed each year.

Analytical Partnerships

In addition to our state-of-the-art research unit, we collaborate with preferred vendors or your chosen partners to ensure the accurate collection, analysis, and interpretation of data using industry-standard methods.

Partner with us to leverage this depth of experience and robust infrastructure for your clinical research success.

Plan for Success: The Path to Approval

Clinical trial success depends on overcoming common pitfalls. We offer the expertise and tools to deliver results efficiently and effectively.

Common Reasons for Clinical Trial Failure

  • Site selection
  • Study design
  • Poor execution
  • Inadequate recruitment

What We Offer

  • Project Management Expertise
    • Cost-effective use of time and budget resources without compromising integrity or compliance.
    • Collaboration to identify opportunities for cost savings.
  • Enrollment Excellence
    • Proven strategies to ensure timely participant recruitment.
  • Meticulous Execution
    • Establishes a firm foundation for subsequent trial phases.
  • Strategic Design
    • Expert input on study protocols and design to optimize trial success.

Efficiency from Start to Finish

Our expertise in early-phase trial design and execution translates to efficiencies that benefit late-phase studies. By addressing challenges early, we help increase success rates for bringing promising products to approval.

Partner with us to achieve your clinical research goals with precision and confidence.