Duke Clinical Research Institute (DCRI) is an academic-based coordinating center for multisite clinical trials, with expert thought leaders across disciplines. The DCRI performs outcomes, comparative effectiveness, and quality of life research. Services include study design, clinical operations, statistics, data management, regulatory support, safety surveillance, and clinical event classification.
The Duke Early Phase Clinical Research Unit is a 30-bed, hospital-based Phase I research unit that conducts early phase studies that require constant patient surveillance. Early Phase has an embedded anesthesiology suite for pharmacology studies, a registry of more than 4000 normal healthy volunteers and a recruitment service.
Researchers seeking clinical expertise and operational capacity to translate preclinical discoveries, new technologies, or device prototypes to humans can collaborate with Duke Early Phase Clinical Research to conduct a broad range of early phase, proof-of-concept, and first-in-human studies.
We partner with pharmaceutical, biotech, medical device, government agencies, foundations, technology companies, and academic centers to accelerate the availability of therapies, diagnostics, technologies, and medical devices to patients.
Our thought leaders optimize clinical trial design to increase operational efficiencies while maintaining regulatory compliance.
At a Glance:
- 34-bed unit, one of the largest academic early phase units in the country
- 50+ personnel experienced in early phase clinical research
- Data analytics/reporting (including PK/PD modeling) that meets FDA reporting standards
- Large healthy and patient volunteer registry
Collaborate with Early Phase:
Contact Juan Martinez at firstname.lastname@example.org or (919) 384-6418 with details about your research question and needs. You will receive a response within 24 hours.
Duke Office of Clinical Research (DOCR) supports the clinical research units (CRUs) that provides tools, training, and resources for site-based research at Duke. DOCR coordinates a research management team of research coordinators, project managers, and data analysts available through a fee-for-service model to support research projects that need part-time support.
Office of Research Informatics (ORI) provides services to support academic research including information technology (vended system selection, custom software development, technical and user support, system integration), academic informatics, research faculty and curriculum development, and data stewardship.
NIH Collaboratory’s Living Textbook of Pragmatic Clinical Trials is a web-based resource of information on conducting pragmatic clinical trials. The textbook’s content is updated continuously and intended for a broad audience ranging from new and experienced researchers to patients and patient advocates.
Registration in ClinicalTrials.gov is REQUIRED for all “Qualifying Trials”, meaning clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1. A ClinicalTrials.gov NCT# must be provided to DOCR for all “Qualifying Trials” before institutional study approval is granted. For more information regarding qualifying trial determination, please click here or contact DOCR.Help@dm.duke.edu.