This dedicated clinical pharmacology unit situated within the Prince of Wales Hospital, provides access to a comprehensive range of medical services and research facilities within the framework of a teaching hospital and the adjacent University of New South Wales. The Unit features restricted access and a fully equipped 16 bed ward, with 24 hour hospital emergency services on-site, which fulfils the safety, control and protocol requirements of Good Clinical Practice (GCP).

The clinical area features a 16 bed ward with two nursing stations allowing close 24 hour observation of volunteers.

Each bed is equipped with a cardiac monitoring system (12-lead ECG, telemetry with full disclosure) with electronic data storage and management capabilities.

Our pharmacy complies with GCP and Good Manufacturing Practice (GMP) requirements for drug preparation, dispensing and storage. This facility includes restricted access, temperature monitoring and mapping of study specific drug cabinets and cold storage areas and is fitted with a security intrusion detector alarm which is monitored to a central agency on a 24 hour basis.

The set-up allows for the following activities in compliance with GMP (as confirmed and approved by GlaxoSmithKline’s GMP Compliance): Pre-packaging/re-dispensing, open and blinded labeling of open labeled bulk/ Phase I supplies, aseptic preparation of solutions (closed systems), reconstitution of powders or liquids and serial dilutions of liquids including those involving aseptic techniques (closed systems).

The Unit maintains a dedicated laboratory which includes a well organized sample preparation area containing standardized equipment for processing and storage of study samples in compliance with GCP and Good Laboratory Practice (GLP).

Secure storage capabilities for study specimens include temperature mapped and controlled -20°C and -80°C freezers with a back-up cooling system, and 2-4°C laboratory refrigerators. All these appliances are equipped with a temperature alarm and 24 hour back-to-base security system. Any out of range temperature fluctuation will trigger an alarm which will alert staff members of any potential problems.

Specialized instrumentation on site includes an ultracentrifuge, five platelet aggregometers, a hematological cell counter, two NIOXX NO analysers and ultrasonic nebulisers, spirometers and other standard respiratory equipment, telemetry, Holter monitors, ABP monitors, a TSAII Neurosensory Analyser, iSTAT® bedside analysers for biochemistry and haematology, and Triage® urinary Drug of Abuse testing systems.

A lounge/entertainment area, dining room and bathrooms are available for volunteer use.
Lunch and dinner menus are prepared by a carefully selected caterer with whom trial specific dietary requirements are discussed to ensure standardized meals are provided to volunteers as specified in the protocols. The unit is equipped with a commercial kitchen which can be used for volunteer meal preparation.  

The unit also has a dedicated recruitment department which includes an in-house call centre, staff offices, a reception area, a secure document archive room, and general storage areas . The unit was redesigned and refurbished in the second half of 2007, to provide a functional and vibrant space for both volunteers and staff.

Medical emergency services are provided by the resuscitation team of the Prince of Wales Hospital on a 24/7 basis.

All staff members are life support trained and a crash cart is maintained to hospital standards and is located in the ward area of the unit. All medically trained personnel in the unit are trained in medical emergencies and the use of the cart.

A 24 hour back-to-base security system monitors the Unit & pharmacy for unauthorized access, freezer/refrigerator temperature failure and fire.