Early Phase Clinical Trials – Australian Advantage

There are lots of reasons to want to execute your early phase clinical trials in Australia. The population profiles and the high standard of clinical facilities make it a cost effective alternative to Europe or the USA. But more than anything else, it is the outstanding advantage of a fast and pragmatic regulatory pathway for phase 1-2 studies that makes Australia such an attractive place for biotech companies to conduct initial clinical trials.

The availability of the Clinical Trials Notification (CTN) Scheme means that our clients can put the need to submit full regulatory submissions to the FDA, EMA, etc. to one side and submit directly to Australian Ethics Committees (IRBs) who under the CTN scheme assume the typical regulatory review responsibility.  This review is done within a usual review cycle of 4-8 weeks based upon a Protocol, Investigator Brochure and perhaps an independent toxicology report.  The result is a much faster timeline into the clinic, avoiding lengthy Regulatory Authority reviews and costly submission dossiers meaning better utilization of limited funding available to many small biotechnology/BioPharma companies.