Why Australia Is The Best Place In The World For Early Phase Studies

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.

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.

• 43.5 % rebate

  • Biotechs can save 43.5% with the Australian Government’s attractive rebate to support clinical trials in Australia

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.