Australian Advantage

The regulatory position in Australia give us an outstanding advantage through the availability to a fast and pragmatic regulatory pathway for phase 1-2 studies (see illustration below). 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 who, under the CTN scheme, assume the typical regulatory review responsibility.  This 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 reviews and costly submission of dossiers. This all means that you can make better use of your money.

The second advantage you will enjoy as one of our clients is access to first in human/patient data much earlier in the development timeline. This will give you a much stronger position in seeking venture capital funding or a licensing partner to fund later stage clinical trials. Because all data from Australasia is readily acceptable by the FDA, EMA and other regulators, IND and CTA submissions can now be made with more confidence and likely success. The Australian Advantage as a strategy is one used by many of our clients to great success. That is why so many of them stay with us right through to phase 2 & 3 or come back to us with subsequent pipeline products.

Both Australia and New Zealand have ageing populations comparable to those of the developed countries where most clinical trial drugs come from. Clinical trial standards are high and practices are similar to those in Western Europe and North America, but with less bureaucracy and lower costs. New Zealand's medical training also encourages doctors to spend time overseas, so many investigators have international experience and are familiar with ICH-GCP and other guidelines. Clinical trial sites in both countries are well organised, with motivated staff and investigators tend to be hands-on involved in clinical trials, meaning a more personal service for patients, better recruitment and retention, and quality data as a result.

Clinical trials conducted in Australia and New Zealand offer the following advantages:

• GCP, GLP, GMP standards to the highest international levels, meaning that you can rest assured that your data/results will be accepted by international regulatory agencies of all types
• language, healthcare systems and clinical practices similar to US/UK,
• approval process efficiency allowing your research to start in a competitive time frame,
• informed and willing population of potential subjects leading to successful study enrolment within time lines,
• highly motivated, experienced, trained (and accredited) research teams producing clean and accurate data,
• high prevalence of certain medical conditions, e.g., melanoma, asthma, and
• seasonality advantages to reduce your recruitment time frame through continuing seasonal studies during northern hemisphere off-season such as flu vaccine studies, allergy, respiratory, etc.