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Clinical Pharmacology Research Unit

Drug Development Unit

School of Medicine Faculty Clinical Research Support Program

Phone #: 410-955-9707
Contact Person: Craig W. Hendrix, M.D.

Facility Director: Craig W. Hendrix, M.D.

Overview

The Drug Development Unit has been organized to provide all the personnel resources and services necessary to design, execute, analyze, and report a clinical research protocol. While our focus and expertise is in the area of inpatient studies of drugs, we offer support for other studies requiring close clinical monitoring. Typically, funding sources are identified by the faculty investigator, but we can provide assistance in identifying industrial sponsors, or in preparation of clinical budgets and protocols to support grant submissions.

 Services Provided

Clinical Research Protocol
Development and Execution

     Clinical Research
     Education/Consultation

  • Protocol development
  • Standard Operating Procedure (SOP) Development 
  • Budget development/proposals
  • Assistance in preparing for FDA Audits
  • IRB and GCRC (General Clinical Research Center) submissions
  • Faculty and staff training in Good Clinical Practices and Good Laboratory Practices
  • Clinical study planning

 

  • Clinical study implementation

 

  • Sample processing, shipping, analytic capabilities

 

  • Data entry/data management

 

  • Quality/Assurance review

 

  • Manuscript/report preparation

 

Expertise and Experience

  • The DDU has completed >128 clinical trials since 1983, including research experience with the National Institutes of Health, the Food and Drug Administration, the Department of Defense and 22 commercial sponsors
  • On-site Quality Assurance Unit, including GLP-Certified staff
  • Clinical staff certified by the Association of Research Professionals (ACRP)
  • Experience with special patient populations

 

Traveling for care?

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Whether crossing the country or the globe, we make it easy to access world-class care at Johns Hopkins.

U.S. 1-410-464-6713 (toll free)
International +1-410-614-6424

 

 
 
 
 
 

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