Duke Early Phase Clinical Research conducts high quality and innovative early phase research to accelerate the availability of therapies, diagnostics, and medical devices to improve the health of every human being.

We specialize in delivering diverse and highly-specialized early phase clinical research solutions.

• Collaborative Partnerships: We work with pharmaceutical, biotech, and tech companies, as well as government agencies, foundations, and academic medical centers to fast-track the development of therapies, devices, and diagnostics.
• Tailored Study Designs: Our team of clinical trial experts creates customized study designs and implementation plans, leveraging deep expertise across various therapeutic areas.
• Reliable Data & Insights: Using industry-standard methods, we ensure efficient data collection, and interpretation to deliver dependable results you can trust.

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

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

• 33 active studies spanning 21 diverse therapeutic areas annually.
• 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.

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.

For any business development inquires, including requesting a proposal or feasibility review of an opportunity, please contact:
DEPRUCRU-BD@duke.edu
 

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.

DEPRU features a 30-bed research facility equipped with clinical trial confinement spaces and six exam rooms. We also offer outpatient facilities for follow-up care and assessments, fully integrated with Duke Health's specialized medical services and equipment.  The unit is located within the Duke South Clinic.

The DEPRU Unit Features
 

Security: The DEPRU Unit has immediate, around-the-clock access to an on-site, full-scale emergency response team and medical provider coverage. The DEPRU Unit also provides extensive security measures for research staff and participants, including alarms, controlled access locks, locked elevators, and Duke Security personnel on-site 24 hours a day.
 

Waiting Areas: The secure DEPRU unit has a dedicated volunteer waiting, check-in, and discharge area. All DEPRU unit visitors are required to sign in, are issued a wristband or name badge, and are then escorted to their meeting location.  Approved secure badge access is provided to Duke personnel.

Examination and Overnight Rooms: The DEPRU unit has well-equipped examination rooms for screening, outpatient visits, or procedures. Adjustable examination tables, electric beds, and infusion chairs are available for use. The overnight stay area has up to 30 participant beds, and each room has access to highspeed internet and Apple TV.  Access to the overnight stay rooms is restricted to those with appropriate credentials.  

Equipment: The DEPRU unit has both Universal Cide Cart and AED for pediatric and adults, and utilizes the Omnicell automated dispensing cabinet and locked medication refrigerators.  The Mortara Telemetry Central System with 16 telemetry channels and Mortara 12-lead ECG machines for continuous monitoring is available in the overnight stay area.  The unit has Welch Allyn Vital Sign machines, Welch Allyn Connex Spot Monitors, and BD Alaris PCU infusion and syringe pumps.

Common areas: If protocol permits, participants can also access our multi-purpose room, a reading room, laundry facility, an outdoor patio, and a large comfortable lounge equipped with games, puzzles, and a high-definition television.

Investigational Pharmacy:  The investigational Pharmacy has a secure on-site location for preparation and dispensing of study product, if needed by the protocol.
Duke Hospital Services: The DUH First Response Team (Team 115) is available for medical emergencies, and a hospital-based IV team with ultrasound-guided intravenous access capabilities is on hand as needed.

Processing Laboratory: The laboratory has two central wet laboratory work areas. All samples are assigned a unique specimen ID at the point of collection; upon receipt by the laboratory, samples are logged in and checked for accurate labeling and assessed for quality prior to processing. 
Each laboratory space houses both a -20°C non-cycling freezer and a -80°C freezer. All freezers are on emergency power backup circuitry. Additional equipment includes: refrigerated centrifuges, one refrigerator (4.0°C), one refrigerator/freezer (4.0°C/-20.0°C), Ohaus Harvard Trip balances, laboratory eyewashes, laboratory safety showers, a biological safety cabinet, a chemical fume hood, ice machines, and micropipettes.

The processing laboratory is staffed by medical technologists experienced in clinical research protocols and sample handling.  In addition to biospecimen processing & shipping, the lab team expertly handles all facets of specimen management, including a robust chain of custody. Samples are promptly processed, split, and frozen as required. Laboratory equipment is monitored and maintained. Capability for short-term storage (up to 90 days) or immediate shipment to central laboratories is available.
 

DUHS Clinical Laboratories are accredited by the College of American Pathologists. Support for protocol-required testing depends on the specific requirements of the research. The DUHS Clinical Laboratories organization is configured to meet the needs of both patients and research subjects, including the range of testing and turnaround time required for specific protocols. Research specimens are handled in similar fashion to incoming clinical samples. For tests not included in the laboratory portfolio, DUHS Clinical Laboratory can use an extensive network of referral labs.

Duke Health Research Volunteer Registry

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

Clinical trials can lead to the development of new drugs, new surgical procedures and devices, that serve to advance healthcare and improve patient outcomes. They can also help doctors learn and advance their research. Many of these medical advances occurred because people volunteered to participate in clinical trials and other types of clinical research. People who participate in clinical trials want to help others, contribute to moving science forward, and also potentially receive investigational products.

The Duke Early Phase Research Unit’s top priority is to protect the health and wellbeing of participants.

Our purpose is to advance health care through research.
 

The Duke Early Phase Research Unit conducts Phase I clinical trials to assess the safety of investigational new drugs and devices (products that are not yet approved for sale in the U.S.) with the end goal of improving patient outcomes by contributing to the development of potential new treatment options.

Early phase research often involves administering an investigational product on healthy, adult volunteers before it is administered in patients.

We are seeking healthy and patient populations to register and participate in our studies.

For clinical research opportunities:

Volunteer Registry

We welcome anyone to join the Duke Health Research Volunteer Registry by clicking the link here.

New Clinical Trials Website and Directory

Duke University School of Medicine, in partnership with the Duke Clinical and Translational Science Institute (CTSI) and the Duke Office of Clinical Research (DOCR), has launched a new community-facing website about clinical research here.