Our Capabilities

Early Phase clinical trial specialists

Q-Pharm has conducted studies with vaccines, biological and pharmaceutical agents, using a broad range of traditional and modern delivery techniques.

Q-Pharm’s experience with comparative pharmacokinetic studies is unrivalled in the region. Our experience base includes:

  • complex designs (steady-state, 3-way and 4-way crossover studies)
  • early stage vaccine trials (including GMOs)
  • large early phase studies (up to 120 volunteers)
  • unconventional study designs
  • extensive experience with food effect studies

Sharon Rankine is our Clinical Operations Manager and is a highly experienced coronary and critical care nurse with extensive experience in healthy volunteer and patient based clinical trials.

First-in-human studies

Q-Pharm is well experienced with conducting pivotal ‘first time in human’ clinical studies.  Our company conducts approximately 30 clinical studies per year, many of which are complex early-phase or first-in-human investigations.  Q-Pharm staff, particularly our medical officers are highly experienced with a wide variety of investigational product types using various routes of administration.

Dr Paul Griffin leads our skilled team of clinical trial doctors. Dr Griffin is an infectious diseases physician and microbiologist. He is also Director of the Infectious Disease Unit at a the Mater hospital in Brisbane as well as a Senior Lecturer at the University of Queensland. Dr Griffin is the Principal Investigator for the majority of Q-Pharm clinical trials and oversees all medical aspects of our clinical trials program.

Healthy and patient based studies

  • First in human
  • BA/BE/PK studies
  • Proof of Concept studies
  • SAD/MAD/Food effect studies
  • Long term confinements (28 days+)
  • Infectious agent – vaccines and therapeutics
  • Anaesthetic agents
  • Malaria challenge models
  • Obesity
  • Glucose clamp
  • Cytotoxic agents and immuno-oncology
  • Medical devices
  • Inhaled deliveries/devices
  • Novel vaccine delivery
  • Ethnobridging & other ethnopharmacology studies

Q-Pharm is at the forefront of innovation within the pharmaceutical and biotech industry.

Together with our clients we have completed many complex trials including ones solving contemporary diseases and viruses such as Ebola and Hendra as well as using innovative technology such as Needle-free Nanopatch technology.

Proven quality system

Many of the clinical studies conducted at Q-Pharm have been accepted internationally for submissions to regulators in Australia, Europe and North America.  Q-Pharm also has a history of successful regulatory inspections and client audits.  Q-Pharm has had inspections by agencies from North America (FDA), Europe (AFSSAPS, AEMPS) and South America (ANVISA).

Our QA team is led by Andrew King, a highly experienced QA professional who is a member of the Research Quality Association. He is responsible for the company's Quality System as well as the role of document manager and archivist. In 2016 Andrew achieved Fellowship of the Research Quality Association.

Specialised expertise

We have run a large number of trials in a wide range of therapeutic areas including:

  • Malaria challenge studies
  • Vaccine studies
  • Gastroenterology
  • Infectious Diseases
  • Dermatology
  • Respiratory
  • Anaesthesia
  • Cardiovascular
  • CNS/Neurology
  • Endocrinology
  • Gynaecology
  • Haematology
  • Medical Imaging
  • Oncology
  • Orthopaedics
  • Psychiatry
  • Renal
  • Rheumatology

Recruitment

Q-Pharm prides itself on timely recruitment of volunteers to ensure your clinical trial proceeds without delay. With a recruitment team boasting over 20 years of clinical trial recruitment experience and state of the art marketing and software systems, we can recruit even the most difficult studies.