Duke Clinical Research Unit
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Duke Clinical Research Unit Early Phase Research Providing you with a unique model for conducting early phase clinical research to accelerate the development of new medical therapies What We Offer • Global network of sites that reaches 80% of the human genome • Harmonized operational network • Extensive database of healthy and patient populations • Real-time protocol optimization and feasibility assessments
What makes us • Thought leadership. As part of the
Duke University Medical Center, we
unique? benefit from the expertise of practicing
clinicians across all therapeutic areas
The Duke Clinical Research Institute’s early
and investigators developing the latest
phase unit, the Duke Clinical Research
research methodologies.
Unit, combines the clinical expertise and
scientific leadership of one of the most • Cutting-edge technologies. We
prestigious university medical centers in the have on-site access to a full array of
world with the operational capabilities of a specialized core laboratories, including
full-service contract research organization. “omics,” advanced imaging, cell therapy,
biobanking, and immune monitoring.
We can carry out your early phase
• Experience. We have more than
and proof-of-concept studies in
20 years of early phase clinical trial
both adults and children and offer a
experience and have successfully
combination of advantages that you
conducted more than 150 early phase
will not find elsewhere:
studies, including Phase I trials.
• Rapid start-up. Our efficient initiation
• Operational excellence. Our staff
process offers a competitive advantage
members are experts in operational
in the race to complete clinical trials on
efficiency and regulatory compliance.
time and within budget.
We’ll help you get your study running
• Patient populations. Through our quickly and efficiently.
massive network of providers and
• Global vision. As a next step, we are
specialized patient databases, we
working to create a global network
have access to disease-specific
of units that offers an unparalleled
subject populations.
toolbox of advanced technologies
• Safety. Our hospital-based unit and capabilities.
provides immediate, round-the-clock
access to an on-site, full-scale emergency
response team and MD coverage.
Full-service operational capabilities
• Data management
• Research coordination
• Subject recruitment
• Wireless, real-time ECG/telemetry
• Randomization
• Biostatistics
• Pharmacy services
• Project management
• Lab sample collection, processing,
and shipping
• Imaging
• Biospecimen collection, storage,
and analysis
Rapid start-up Types of studies
Early phase studies
We offer two-week turnaround on all
• Proof-of-concept
Institutional Review Board submissions,
using an external AAHRPP-accredited • Healthy volunteers
IRB. We expedite contracting, using one • First-in-human
point of contact for agreements, including Complex research
Confidential Disclosure Agreements and • Special populations
Master Trials Agreements execution.
• Long-term confinement
• Sophisticated experimental designs
Biological mechanistic studies
Thought leadership • ADME
We work with more than 800 Duke • Bioavailability
University Medical Center faculty • Bioequivalence
members, who are recognized leaders in
• Biomarkers
their fields, have a personal understanding
of clinical practice settings, and have • Bionutritional
direct, current experience at the bedside. • Drug-drug interactions
We work with clinical investigators and • Drug-food interactions
PhDs in quantitative sciences who have • Drug metabolism
specialized expertise in emerging clinical
• Endotoxin
research methodologies.
• Escalating dose
• PK/PD/PG
Imaging research
• CT
• EchoMRI
• Functional MRI
Therapeutic areas of expertise
Direct access to
• Allergy/Immunology
• Anesthesiology
patients
We are one of only a few research
• Bariatric Surgery
units in the United States with access
• Cardiac Surgery
to disease-specific pediatric, adult, and
• Cardiology geriatric populations.
• Clinical pharmacology
Using sophisticated patient databases and
• Endocrinology a comprehensive data warehouse, we can
• Gastroenterology find and screen the patients that you need
• General Surgery for your study in real-time.
• Geriatrics
• Hematology
• Hepatology
• Infectious Diseases
• Medical Genetics
• Metabolic Disorders
• Nephrology
• Neurology
• Neurosurgery
• Oncology
• Ophthalmology
• Pediatrics
• Psychiatry
• Psychology
• Pulmonary Medicine
• Radiation Oncology
• Rheumatology
• Urology
Case study
The DCRU offers sponsors a unique model for conducting clinical studies such as endotoxin
human challenge trials. The lipopolysaccharide complex (LPS) human endotoxin challenge
model produces a well-characterized, transient acute inflammatory response in patients. This
model has been widely used as a system to study new therapeutic agents for inflammation
before wider clinical studies are undertaken.
Utilizing the human endotoxin challenge model, the DCRU has learned to recognize the
effects of endotoxin and to work with sponsors in helping them to evaluate the potential
effects of their drugs in the presence of the expected symptoms associated with LPS. As one
of the few facilities able to conduct these studies, the DCRU is well-equipped to help sponsors
better understand this model and thereby save time and money developing their protocols.
First-class facilities The DCRU early phase unit also offers:
• Dedicated subject recruitment team
The DCRU early phase unit operates
• Seven exam/procedure rooms
specialized facilities for both adults and
and screening areas
children on the Duke University Medical
Center campus. Our 17,000-square-foot • An outpatient facility with more than a
dozen infusion chairs
Adult unit includes 30 confinement beds.
• A metabolic kitchen with trained
Our hospital-based units maximize registered dietitians, who can provide
subject safety and provide on-site access regular, therapeutic, and research diets;
to a full array of specialized procedures controlled feeding studies; and infant
and technologies. We have immediate, formula preparation
round-the-clock access to an on-site,
• Fully-equipped specimen collection,
full-scale emergency response team processing, handling/shipping, and
and MD coverage. storage laboratories
• Attractive and comfortable subject
spaces with a recreational area, reading
room, dining room, laundry facility, and
secured patio
• A 700-square-foot space for conducting
specialized procedures
• Investigational pharmacy and
chemotherapy pharmacy services
• Special amenities for subjects, such as
valet parking
• Extensive security measures, which
include cameras, alarms, locked
elevators, and Duke security personnel
who are on-site 24 hours a day
• Affordable patient housing for
confinement studies
Cutting-edge • Specialized “omics” equipment
and expertise. Our on-site and
technology off-site Omics facilities perform high
throughput assays and data analysis
We offer access to a variety of core
for genome sequencing, genotyping,
laboratories, all equipped with a wide
gene expression, proteomics, and
spectrum of cutting-edge technologies to
metabolomics to study the effects
better understand disease and predict drug
of medical interventions on human
response. For example:
physiology and disease states.
• Real-time ECG collection, monitoring,
• Ability to receive cellular products
and interpretation. We use Mortara®
(frozen, refrigerated, or room
wireless 12-lead, 24-channel ECG digital
temperature). Our Cell Therapy lab
telemetry, allowing for easy transfer
prepares products for infusion according
of data.
to suppliers’ specifications and creates
• Ability to examine the subtle effects appropriate infusion records.
of medical interventions on the
• State-of-the-art, highly secure image
human immune system, including
management and digital archival systems
immunogenicity, immunocompetence,
and world-class consultative services.
immune reconstitution, and
Our Imaging lab offers advanced nuclear
immunotoxicity. Our Immune Monitoring
imaging, echocardiography, and spectral
laboratory uses immunoassays that
domain OCT scanning technologies.
are robust and reproducible, highly
sensitive and specific, and fully • Data integration. Our informatics
validated and standardized to support capabilities include extensive experience
multi-center studies. in combining phenotypic and biological
marker data.
Global vision The DCRU is working to create a global network of early phase clinical research units with the ability to evaluate pharmacogenomics across ethnically diverse populations by harmonizing operational processes and IT systems, increasing efficiency through economies of scale, and providing an unparalleled toolbox of advanced technologies by combining resources. Produced by the Duke Clinical Research Institute (DCRI) Department of Communications • August 2013
Contact us
For more information about
the Duke Clinical Research Unit, contact:
919.613.6244
dcrurecruit@duke.edu
visit dcru.org
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