The DEPRU address and location:
40 Medicine Circle
Clinic 3N
Durham, NC 27710
We are located in the Duke Clinic building which is connected to the Duke Medicine Pavilion and the Duke Cancer Center.
About DEPRU
Duke Early Phase Research Unit (DEPRU), a service center, is a Duke School of Medicine Clinical Research Unit (CRU) positioned within the Duke Office of Clinical Research. DEPRU supports the design, development, implementation, and conduct of Phase I-II clinical trials, including first-in-human and proof-of-concept studies in healthy, special, and disease-specific populations.
The DEPRU CRU’s alignment with Research at Pickett Road also allows for seamless management of a diverse range of studies, including validation device studies and later phase research. We provide services to the entire Duke health system. Researchers from every department can utilize our resources to get their human research off the ground.
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.
The Path to Proof
Facilities
Our early phase unit, DEPRU, offers a safe and comfortable environment for healthy volunteers and patients participating in our research studies.
This is a 30-bed well-equipped research facility with clinical trial confinement space, 6 exam rooms, and an on-unit continuous temperature and humidity monitoring of Processing Lab and Pharmacy areas.
Amenities
Participants have access to wireless Internet throughout the clinic and televisions in their shared rooms. If protocols permit, participants can also access our multipurpose room, laundry facility, and a large, comfortable lounge equipped with games and television.
Security
We have immediate, around-the-clock access to an on-site, full-scale emergency response team and medical providers coverage. The Early Phase Unit also provides extensive security measures for research staff and participants, including alarms, locked elevators, and Duke Security personnel on-site 24 hours a day.
Our Services and Staff
Duke Early Phase Research Unit, A Service Center
We offer a full range of services:
- Comprehensive early phase research services
- Accelerated delivery
- Specialized facilities and technologies
- Rapid health and patient recruitment
- Study design
- Clinical research conducted by highly trained and dedicated clinical research professionals
- Experienced nursing services
- Processing laboratories
Available Services and Staff
Our laboratory facilities include a range of sample storage options, continuous temperature and humidity monitoring, and the ability to support high volume sample processing.
Our laboratory Medical Technicians are committed to meticulous processing and are highly experienced with management of serial PK samples.
For more specialized lab processing (e.g., PBMCs), other lab bioanalysis, or assay needs, the DEPRU is proximal to Duke University Health System (DUHS) Clinical Laboratories, and other core clinical and research facilities with whom we routinely collaborate to support these services. The DUHS Clinical Laboratories have the ability for 1 hour processing of safety labs.
Available Laboratory Equipment
- Laboratory processing and storage area with temperature-controlled centrifuges
- Refrigerators
- -20°C and -80°C freezers and access to dry ice
- Heat block
- Biological Safety Cabinet (BSC)
- Chemical Fume Hood
- Water Bath
- Adjustable Pipettes
- Analytical Balance
DEPRU nurses deliver care to research participants, which includes but is not limited to:
- Safety monitoring
- Administration of investigational products
- Vital signs assessment
- IV and port access
- Phlebotomy
- Sample collection
- Data entry into source documents (e.g., study plans)
- Gathering of medical/surgical histories, current medication usage, and recording of any unanticipated events
- Performing electrocardiograms (ECGs)
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.
Nursing Equipment
Our nursing equipment includes:
- Mortara Telemetry Central System with 16 telemetry channels
- Mortara 12-lead ECG machines
- Welch Allyn Vital Sign machines, Welch Allyn Connex Spot Monitor
- Fully stocked emergency crash carts with suction, AED, oxygen
- Central temperature and humidity controlled Omni cell, Labcool, and locked medication refrigerators
- BD Alaris PCU infusion and syringe pumps
- Master clocks with synchronized time
Our Clinical Research Professionals include:
- Clinical Research Coordinators
- Clinical Research Nurse Coordinators
- Clinical Research Specialist Senior
- Regulatory Coordinators
- Research Program Leaders
Our dedicated clinical research professionals are highly trained and experienced. Our team completes data entry and has experience with multiple Electronic Data Base (EDC) Systems.
Our dedicated recruitment team is a group of experts who utilize innovative and dynamic tools, such as SlicerDicer and MyDukeHealth messages, to streamline the recruitment process for investigators and study teams.
Volunteer For Research
Clinical Trial Participation
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.
Early Phase Clinical 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.
Functional Service Provision
DEPRU’s clinical research experts are enthusiastic about accelerating timelines, leveraging internal expertise for planning and strategic implementation, maximizing efficiency, and exceeding quality standards.
Areas where you can count on our expertise to drive superior performance:
|
Study Design & Protocol Development |
Project Management |
| Strategic Feasibility | Clinical Monitoring |
| Regulatory & Ethics Submissions | Data Provenance |
| Quality & Compliance | Diverse Therapeutic Areas & Pathologies |
| Recruitment | Core and Processing Laboratories |
| Study Coordination |
Partner With Us
Plan for Success - The Path to Approval
What we offer:
-
Enrollment excellence and robust recruitment solution capabilities
-
Collaboration with an extensive network of internal support resources
-
Strategic design input through expertise and protocol input or development
-
Meticulous execution
-
Firm groundwork for subsequent trial phases
-
Transparency during feasibility review and layered assessment of studies prior to intake
Our therapeutic areas of expertise in Clinical Research include:
| Neurology | Neuroscience |
| Anesthesiology | Endocrinology |
| Geriatrics | Gastroenterology |
| Hepatology | Hematology |
| Cardiology | Pediatrics |
| Dermatology | Infectious Diseases |
| Vaccines | Pulmonology |
Opportunity Review
Identifying the appropriate expertise
Planning
- Protocol development
Start-up
- Effective study start-up process
Implementation and Conduct
- Single point of conduct
- Project Manager
- Risk mitigation
- Ensuring high quality data
DEPRU Advantages
- Access to Duke University Health System Patients
- Infrastructure and experience to ensure data quality and integrity (evidenced by our excellent reputation with regulatory authorities)
- A thriving healthy volunteer research registry with a dedicated and highly skilled recruitment core
- Diversity among research volunteers and patients
- Agility in study conduct and robust resource capabilities given our integration under the Duke Office of Clinical Research
- Broad-ranging and specialized procedure capabilities
- Faculty with expertise in protocol development, clinical trial design, and early phase trial execution
- Partnership with Duke Clinical Research Institute for trials with full-service needs
- Reliable and competitive pricing
- On-unit processing laboratory
- Specialized functional groups comprised of clinical research experts and dedicated clinical staff and faculty
Programmatic Interests
- Filling gaps in current portfolio
- Testing new technologies and approaches
- Addressing questions that will advance public health
- Accessing patient populations with unmet needs
- Leveraging scientific knowledge and experience to successfully deliver on complex trials
For any business development inquires, including requesting a proposal or feasibility review of an opportunity, please contact:
Jessica Ashworth, Research Program Leader jessica.ashworth@duke.edu
Wan Lan Liang, Research Practice Manager wan.liang@duke.edu
You might consider having a Mutual Confidentiality Agreement in place.