University of Louisville Clinical Trials Unit Outpatient Clinic

Center Information

Rachel Sheppard, MBA, CCRA, CCRC
Clinical Regulatory Director
University of Louisville Clinical Trials Unit Outpatient Clinic
401 East Chestnut Street, Suite 460
Louisville, KY 40202
USA
502-852-1006
502-852-2610 (fax)
ctu@louisville.edu
louisville.edu/research/ctu
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Currently Enrolling Trials

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Video Presentations

Therapeutic Areas

Cardiology/Vascular Diseases
Devices
Endocrinology
Family Medicine
Gastroenterology
Genetic Disease
Healthy Volunteers
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Ophthalmology
Otolaryngology (Ear, Nose, Throat)
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)
Urology
Vaccines

Center Overview

The University of Louisville Clinical Trials Unit (CTU) is dedicated to promoting and facilitating inpatient and outpatient clinical research at the University. The unit is centrally located on the downtown medical campus and is easily accessible to research patients and healthcare researchers. The CTU serves all of the medical faculty of the University and offers a centralized, streamlined approach to human subject research. The fully staffed research unit can accommodate most all inpatient and outpatient research studies. The CTU also offers full contracting, financial and regulatory support.

Performance Metrics

Number of Studies Conducted: 200-300/year

ACRP Certifications

Clinical Research Experience

The University of Louisville is proud to feature renowned faculty with clinical and research experience in many areas including:

  • Anesthesiology
  • Cardiology/Interventional Cardiology
  • Endocrinology/Metabolism
  • Gastroenterology/Hepatology/Nutrition
  • General Surgery
  • Infectious Diseases
  • Medicine
  • Neurological Sciences
  • Ophthalmology
  • Pulmonary/Critical Care
  • Transplant
  • Urology
  • Vascular Surgery

Facility Description

The CTU features five fully furnished exam rooms, infusion center and a processing laboratory (CLIA certified). The facility can accommodate all types of research requirements from Phase-I through Phase-IV.

Facility Equipment:

  • -70°C specimen freezers
  • -20°C specimen freezers
  • -2°C to 8°C specimen refrigerators
  • -2°C to 8°C drug storage refrigerator
  • Refrigerated centrifuges
  • Ambient centrifuges
  • 24/7 temperature monitoring/logging
  • InBody 770 body compilation analyzer
  • Oxygen concentrator and bottle fill system
  • Monitor work areas
  • Research drug storage room (temperature controlled-limited access)
  • Double lock drug cabinets

There is convenient parking connected to the Outpatient Center via a pedway as well as direct access to the University of Louisville Hospital. For additional facility information, please see the UL Research Foundation page at http://www.centerwatch.com/news-resources/research-centers/profile/2292/university-of-louisville-research-foundation-ulrf.

Investigator Experience

The University of Louisville is priviledged to have many renowned researchers:
https://search.knodeinc.com/louisville/index.action

Staff Expertise

The CTU employs 2 nurse practitioners and 16 full time clinical coordinators. The professionals in this office have an average of ten years of experience in clinical research. These personnel have education/certifications in the following areas: Clinical Research Professional Clinical Research Associate Clinical Research Coordinator Masters of Business Administration Certified Public Accountant Bachelors of Nursing Masters of Nursing For specific personnel information, please see the following website: http://louisville.edu/research/ctu/about/administrative-staff http://louisville.edu/research/ctu/about/clinical-staff

Patient Demographics

The patient population comprises of patients from most of Kentucky and Southern Indiana counties and surrounding states. U of L serves a unique patient population. Kentucky sits in the midst of “Coronary Valley” and the “Stroke Belt” with high prevalence of heart disease, obesity, diabetes, stroke, and lung cancer. Unfortunately, Kentucky is also a ‘leader’ in low educational achievement and high levels of smoking, and alcohol use. These factors combine to make Kentuckians especially unhealthy. Its African-American, Hispanic, Appalachian, and indigent populations are large, and they are disproportionately afflicted with above noted chronic diseases. Therefore, the CTU is well situated to perform clinical and translational research with multiple diverse/minority populations to positively impact the health and well being of these subjects. Kentucky is tied for second in overweight adults and obese adults, ninth in hypertension, seventh in diabetes, second in physical inactivity and sixth in the highest poverty rates. Segments of Louisville Metro have the highest rates of many of these diseases in the state.

Other Information

or Sponsors The CTU is the central clinical trials office at the University of Louisville. The CTU is the best point of contact for industry sponsors. The office provides information and communication about clinical research at University of Louisville. CTU is your contact to: Identify principal investigators with particular research expertise and interests (Investigator Identification Service) Obtain general information about clinical research resources, research capabilities, and sponsored research administration Streamline communications among sponsor, research administrators, PI and research personnel CTU is a full service research support office that provides the following services: Protocol feasibility Regulatory submission and documentation Budget development and negotiation Billing plan development Contract routing Clinical coordination For more information: http://louisville.edu/research/ctu/services For information regarding utilizing the CTU outpatient clinic facilities and resources, please contact the Research Operations Manager, Chris Cunningham, PhD at (502) 852-2906 or chris.cunningham@louisville.edu

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.