Clinical trials

Melbourne is a premier location for clinical trials and builds on its strong foundation of talent, access to world-class infrastructure and a flexible and rapid regulatory framework for approval of clinical trials.

Victoria’s experienced clinicians and can facilitate access to both patients and 'trial-ready' infrastructure and clinical trials in Australia benefit from fast approval times, globally recognised quality, research and development tax incentives and extensive patent protection systems.

One-third of Australian clinical trials activity takes place in Victoria. Pharmaceutical and biotech companies recognise Australia's impressive capability and many have chosen to undertake trials here.

Victoria adheres to the highest level of Good Clinical Practice standards, with Australian clinical data and results accepted by international regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency.

Australia's Clinical Trial Notification scheme provides an expedited regulatory pathway for phase I trials, with over half being receiving ethical approval in less than 20 days and 87 per cent receiving ethical approval in less than 30 days.

Ideal location to conduct a broad range of clinical trials

Several leading US drug discovery firms are making major investments for world-first clinical trials in Victoria to tackle malaria, arthritis, asthma, neuro degenerative disorders and heart conditions, recognising Victoria’s capabilities in biotechnology, medical and pharmaceutical research and development. Examples include:

  • San Francisco firm Kezar Life Sciences will conduct world-first clinical trials in Melbourne for a drug that could help treat autoimmune and inflammatory disorders such as rheumatoid arthritis and lupus.
  • San Francisco firm Annexon Bioscience has established its Australian subsidiary in Melbourne to further its work in neuro degenerative research.
  • Merrimack Pharmaceuticals, a Massachusetts-based oncology drug development company, is conducting multiple clinical studies in lung and pancreatic cancer with two of its late-stage therapeutics.
  • Synermore Biologics, with its Maryland-based founder, has been conducting a ‘first in human’ trial on a drug to tackle asthma and allergic rhinitis, with additional clinical trials for other biological products in planning stages.
  • San Francisco-based InCarda Therapeutics Inc has also established a subsidiary in Melbourne, continuing their work in pioneering a novel approach to treating cardiovascular diseases via the inhalation route.

Victorian-based clinical trials expertise

Best practice clinical trials networks and contract research organisations throughout Victoria ensure access to volunteers and fit-for-purpose infrastructure led by world leading clinicians.

Cancer Trials Australia offers a combination of clinical and research skills, access to clinical trial diagnostic and monitoring equipment and centralised administration of clinical trials in medical oncology, haematology and bone marrow transplantation.

Nucleus Network is an Food and Drug Administration audited, National Health Surveillance Agency Brazil accredited, dedicated phase I clinical trials organisation with extensive experience in first in human, proof of concept, pharmacokinetic and pharmacodynamic, TQTc, bioequivalence, drug or food interaction studies and biosimilar and vaccine trials.

St Vincent’s Hospital Melbourne has introduced the Research Valet® Service. Two levels of service are available: Valet and Concierge.

Valet includes full Human Research Ethics Committee (HREC) submission preparation and liaison throughout the submission and approval process.

Concierge offers HREC pre-review and ongoing liaison during HREC or governance review.

Sponsors or researchers will receive full approval within 30 days of HREC meeting and governance approvals will be targeted at seven days after submission of all required documentation.

Neuroscience Trials Australia is a niche contract research organisation specialising in neuroscience clinical research.

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