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CMUH

China Medical University Hospital Clinical Trial Center

CMUH

CMUH is well staffed and well equipped for conducting clinical trials and studies and translational research. It boasts the most efficient institutional review board which meets weekly to speed up the heavy demand for reviewing clinical trial and clinical research protocols involving human subjects or materials. CMUH has developed the most rigorous clinical protocol review system, data management, monitoring/auditing mechanisms under the supervision of a well established Clinical Trial Center of Excellence Clinical Protocol Scientific Review & Monitoring Committee and an advisory committee consisting of 15 world renowned experts in stroke and neurological diseases. All phases of clinical trials follow the guideline of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). CMUH investigators also have extensive experience in pharmacokinetics including those involving extracted ingredients and synthetic derivatives from traditional Chinese medicine for clinical trials.
 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2001
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Vaccines
  • PopulationsChild 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteAcademic
  • # of employees involved in research300
  • # of investigators101
  • Number of studies last year228
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL, Other
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsSheng-Fen Huang
  • Regulatory phone number886-4-22052121 ext.1926
  • Type of IRB used by this siteLocal
  • How often does your local IRB meet?Monthly
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contractWithin 1 month