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Phase 1 Clinical Trials Centre

The HKU Phase 1 Centre is a dedicated, modern clinical research facility specifically designed for conducting phase 1, early phase and clinical pharmacology trials. Equipped with state-of-the-art equipment and staffed with leading clinical/scientific experts and a professional management team, the HKU Phase 1 Centre is capable of conducting various types of phase 1 and early phase trials in novel chemical/biological drugs as well as bioavailability/ bioequivalence (BA/BE) trials, whether in patients or healthy volunteers.

The HKU Phase 1 Centre has been accredited by the China Food and Drug Administration (CFDA) since July 20, 2016.

Facility/Area Feature
Overall
  • Dedicated, fully-controlled clinical research facility
  • Strategically located in the major clinical building (Block K) of QMH
  • Card access control
  • Synchronized clocks
  • Full Wifi coverage
Clinical Area
  • 24 beds in 4 cubicles
  • Central nurse station positioned within the bed-area for easy monitoring of study participants
  • Central physiological monitoring system connecting to bed-head physiological monitors and telemetry system
  • Surveillance camera system for supporting safety monitoring
  • Dedicated resuscitation room for medical emergency
  • 24-hour support by QMH’s central resuscitation team and intensive care unit (ICU)
Study Drug Management Facility
  • Card access control
  • Dedicated drug storage room with 4°C and -20°C refrigerators (for refrigerated drugs) and temperature and humidity-controlled cabinets (for ambient temperature drugs)
  • Dedicated drug processing room (separated from the drug storage room) for controlled processing of study drugs, with biosafety cabinet for drug reconstitution and electronic balances for dose adjustment
  • Emergency electricity backup, uninterrupted power supply and 24-hour monitoring and alarm system for all refrigerators/freezers
  • Regular maintenance/calibration for major equipment (with full documentation)
Biological Specimen Management Facility
  • Card access control
  • Two dedicated biological specimen processing rooms with refrigerated centrifuges and biosafety cabinet for supporting two concurrent studies
  • Dedicated biological specimen storage room with -20°C and -70°C freezers
  • Emergency electricity backup, uninterrupted power supply and 24-hour monitoring and alarm system for all freezers
  • Regular maintenance/calibration for major equipment
Leisure and Dining Area
  • Dedicated leisure and dining area for study participants
  • Lockers for keeping study participants’ personal belongings
  • Internet bar and entertainment facilities
Wet Area
  • Male and female toilets
  • Shower room
  • Assisted toilet and shower room
  • Emergency nurse call in each toilet/shower compartment
  • Housekeeping room with a separate exit