- Foreword
- Advisory Board
- Introduction - CCT
- Training and Education
Provided by CCT
- SFDA Inspection and Accreditation
- Ethics Committee
- Central Laboratories
- Clinical Trials Capabilities
 Cardiology
 Clinical Oncology
 Digestive and
 Liver Diseases
 Endocrinology
   Ophthalmology
   Phase I Studies Unit
   Paediatrics
   Anaesthesia and
 Intensive Care
   Community and
 Family Medicine
   Neurology
   Orthopedic and
 Traumatology
   Psychiatry
   Rheumatology
   Surgery
 
 

Clinical Trials Capabilities > Phase I Studies Unit

Strength and Expertise

The Phase I Studies Unit is a fully functional clinical investigation site, which has the capacity for performing a wide range of clinical studies (e.g. bioequivalence, Phase I to Phase IV studies) on healthy volunteers as well as hospital patients. Much effort and resources have been devoted in the establishment of the Phase I Studies Unit following the principles and guidelines of Good Clinical Practice (GCP). Over the years, numerous clinical studies have been performed at the unit for various international pharmaceutical companies, including a number of Phase I drug trials requiring overnight evaluations.
The Drug Development Centre (DDC) aims to provide drug development services for the pharmaceutical and health supplement industries. The bioanalytical unit of the DDC has been accredited under ISO/IEC 17025 of the Hong Kong Laboratory Accreditation Scheme (HOKLAS) for the chemical testing of various pharmaceuticals (Registration No.: 147). The services provided by the DDC include: biopharmaceutic/pharmacokinetic studies, pharmacodynamic studies, drug interaction studies, formulation development, stability testing, chemical and physical characterization, bioanalytical assay development and validation, acute and chronic safety/toxicity studies.

Special Facility and Equipment

  • Specialized in pharmacokinetic, Phase I, and Phase IIA study
  • Capable to perform overnight evaluations on patients and healthy volunteers (max. 20 beds)
  • Equipped with emergency medications and resuscitation equipment
  • Equipped with sample processing equipment on-site
  • Dedicated sample storage facility (incl. -20¢XC and -80¢XC freezers)
  • Secure storage for medications with temperature control

Disease Types and Number of Patients Potential for Clinical Trials Recruitment

  • Maintains a database of over 200 healthy volunteers for Phase I and pharmacokinetic studies
  • Over 50 pharmacokinetic studies completed
  • Over 200 healthy volunteers recruited for Phase I clinical trials
  • Over 1,000 subject visits arranged

Clinical Trials Monitored and/or Audited by Industry, FDA and local RGC etc.

Phase I studies have been audited by European, Japanese and local agencies