Capabilities

Our experienced clinical research team can help you assess safety, identify risks and clarify your early stage development path. We have strong expertise to help to:

  • Assist you to accelerate proof of concept
  • Establish dose escalation regimens
  • Access our extensive network to support study-specific pharmacodynamic (PD) requirements
  • Undertake specialist studies, such as ethno-pharmacology, TQT, ADME, drug interaction
  • Adhere to globally consistent quality standards for patient safety and regulatory guidelines

Facilities
We have two purpose-built, clinical facilities that are fully equipped with all of the latest medical technology to ensure the safety of our healthy volunteers and patients

  • Telemetry
  • Call bell service to all beds
  • Oxygen & suction to all beds
  • Recreational and computer rooms
  • Dedicated study monitor area
  • Laser doppler
  • Pulse oximetry
  • Holter monitors
  • Technical laboratory with temperature controlled centrifuges
  • Temperature monitored -70⁰C, -20⁰C and 2–8⁰C storage facility for samples

Specialist clinical capabilities
We can also provide extensive specialist clinical capabilities, such as:

  • Cardiology – Echo, ECG, Holter monitoring, TQTc
  • Pain assessments – Von Frey and Thermostimulatory Analysis (TSA)
  • Immunological PD markers – PBMC isolation, cytokine assessments, anti-PEG Ab, cytokine stimulation assays
  • Oncology – epigenetics, functional imaging, cell based assessments, radio-chemistry including Ab, Ab-fragments and small molecules

Specialist onsite clinical capabilities

  • Cardiology – Echo, ECG, Holter monitoring, TQTc
  • Vascular  – Duplex scans
  • Respiratory function testing – Body Box, NO2 assays, FEV1
  • Neuroscience testing – Ultrasound, EEG, EMG, NCS, evoked potentials
  • Pain assessments – Von Frey and Thermostimulatory Analysis (TSA)
  • Sleep laboratory testing
  • X-Ray, CT, MRI, MRS
  • PET scanning
  • Allergy testing – basophil activation; gluten challenge, nasal challenge
  • Immunological PD markers – PBMC isolation, cytokine assessments, anti-PEG Ab, cytokine stimulation assays
  • ADME – C14 labels, continuous bile sampling
  • Punch biopsies
  • Oncology – epigenetics, functional imaging, cell based assessments, radio-chemistry including Ab, Ab-fragments and small molecules
  • HLA genotyping
  • Internal CYP genotyping database

Pharmacy services

  • Four full time Clinical Trial Pharmacists
  • On-site compounding
  • Blinded packaging, comparator supply, labelling, import permits and temperature monitored storage
  • Radio-pharmacy
  • Clinical trial manufacturing, packaging and logistical services and small scale secondary packaging services
  • Access to a cGMP TGA licensed facility
  • Quarantined storage of Clinical Trial Supplies prior to local ethics approvals to enable faster trial start up