Why Australia is the best place in the world for Early Phase studies
The Australian Advantage is about saving time and minimizing costs while generating internationally accepted data in preparation for the next Phase.
The Australian regulatory framework is considered to be the fastest in the world for approving and undertaking Early Phase clinical research trials. Central to the accelerated clinical process is that an IND is not required in Australia, which means extremely rapid start-up for biotechs, often in under 5 weeks. Biotechs can also leverage up to 43.5% in rebates to further reduce costs. Meanwhile the exceptional scientific and medical research environment offers world-leading clinical settings for early Phase trials.
CONTACT OUR IN HOUSE SCIENTIFIC & REGULATORY AFFAIRS TEAM IN AUSTRALIA, NORTH AMERICA AND EUROPE
Delivering more than 30 years experience of drug development expertise
The Australian Advantage
Time and cost savings
No IND required
Our biotech clients start their Phase I without having to wait for an IND, saving up to a year in regulatory processing times and considerable costs.
Rapid IRB/EC approval
Our clients are currently experiencing a 3-week IRB/EC turnaround due to the supportive regulatory and clinical environment, and Avance Clinical’s experience.
World-class data
Avance Clinical data is accepted by all the major regulatory authorities including the FDA and EMA.
Proven site network across Australia and New Zealand
Avance Clinical has a powerful Australian and New Zealand network of proven PIs and clinical sites.
5-6 week start-up
With the Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks it enables you to get access to clinical data quickly and gain that critical Go/No Go information on your product faster than anywhere else in the world.
Up to 43.5 % rebate
Biotechs can save 43.5% with the Australian Government’s attractive rebate to support clinical trials in Australia
What is The Australian Advantage
How does it maximize Benefits for US Biotechs?
This approach offers US biotech firms numerous benefits, including a cash rebate of almost 50%,
faster timelines, no IND requirement, and globally accepted data.
The Australian and Avance Clinical Advantage – No IND Required
The Australian Regulatory Framework is the fastest in the world for undertaking Early Phase clinical research trials.
No IND required
Our biotech clients start their Phase I without having to wait for an IND, saving up to a year in regulatory timelines and considerable costs.
Rapid IRB/EC approval
Our clients are currently experiencing a 3-week IRB/EC turnaround due to the supportive regulatory and clinical environment, and Avance Clinical’s experience.
World-class data
Avance Clinical data is accepted by all the major regulatory authorities including the FDA and EMA.
COVID-19 success
With almost 50% of adults vaccinated, Australia has prioritized clinical research as an essential service which supports Avance Clinical’s biotech clients, clinical sites, and patients seeking access to therapies.
Proven site network across Australia and New Zealand
Avance Clinical has a powerful Australian and New Zealand network of proven PIs and clinical sites.
5-6 week start-up
With the Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks it enables you to get access to clinical data quickly and gain that critical Go/No Go information on your product faster than anywhere else in the world.
The Australian Regulatory Processes
The Australian regulatory body for clinical trials, the Therapeutic Goods Administration (TGA), offers two schemes for conducting clinical trials in Australia:
- the CTN Scheme
- and the CTX Scheme
As an experienced CRO, Avance Clinical has extensive experience with both these schemes. Benefits include:
- Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 Weeks.
- Working within this robust and efficient framework accelerates clinical trials.
- No IND is required for clinical research trials
- Full GMP material is not mandated for Phase I clinical research trials
Avance Clinical has been supporting international biotechs in their clinical drug development processes for regulatory approval for the past two decades.
get in touch with our
clinical operations team
Delivering more than 30 years experience of drug development expertise
ClinicReady Success Story
Tetherex Pharmaceuticals
"The Avance team demonstrated flexibility and a solution-oriented attitude in working with us towards obtaining rapid ethics approval, thereby facilitating trial initiation in a timely and efficient manner." - Dr. Russell Rother, President and Chief Operating Officer
