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The Australian Advantage

The Most Attractive Place in the World for Clinical Trials

The Australian and Avance Clinical Advantage - No IND Required

The Australian and Avance Clinical Advantage is all about the rapid start-up, leveraging up to 43.5% rebates to reduce costs, and delivering internationally accepted quality data from world-leading clinical settings, KOLs and PIs.

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 Framework is the fastest in the world for undertaking early phase clinical research trials.

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The Clinical Trial Environment

Australia has a supportive regulatory environment designed to ensure studies can progress quickly from start-up to the first patient in within 5-6 weeks.

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 schemes offered by the TGA.

  • Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 Weeks.
  • Working within this robust and efficient framework expedites the process of running a clinical trial.
  • No IND 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.

The Clinical Trial Rebate Program

The Australian Government’s Research and Development Tax Incentive has made Australia an even more attractive destination for clinical trials.

  • Offering the world’s most attractive cash benefit to companies with an aggregated turnover of less than $20 million that are in a tax loss position.
  • Recover up to 43.5 cents from every dollar spent on R&D, or reduce tax by up to 15%
  • Manage cash-flow
  • Improve R&D project and knowledge management
  • Ensure compliance with R&D legislation
  • Spend almost double on your clinical program in Australia

Avance Clinical can put you in direct contact with advisors that will help facilitate easy, and cost-effective access to the Australian R&D Tax Incentive.

Established healthy subject databases, specialised patient populations
Five independent Phase 1 facilities across Australia including hospital-based units for critical care
Dedicated Investigators committed to clinical research
Major hospitals with world-class infrastructures and dedicated Clinical Trial Units
Expedited clinical trials for influenza & allergy related studies
Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons
Ethnic Comparison Studies

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The Australian Government R&D grant means up to 43.5% rebate on clinical trial spend
Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks
Globally accepted data
No IND required for clinical trials

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More benefits

Avance Clinical can leverage all the benefits of Australia and New Zealand’s clinical ecosystem to deliver your study

Almost half clinical costs

The Government R&D grant means up to 43.5% rebate on clinical trial spend

Rapid Start-up

Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks

Start-up time

Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks

No IND

No IND required for clinical trials

GMP material

Full GMP material is not mandated for Phase I clinical trials

Gene-therapy accreditation

Avance Clinical is an accredited gene-therapy CRO

Seasonal studies

Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia and New Zealand's counter-flu and allergy seasons

FDA and global regulatory data compliance

Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track record in FDA compliant research
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Book a Meeting with us
Book a Meeting with us

Rebate

The Government R&D grant means up to 43.5% rebate on clinical trial spend

Start-up time

Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks

Capabilities

Full service CRO in Australia and New Zealand

Learn About our COVID-19 Capabilities

Learn more about us here

360
Studies in the past 5 years
300
Experienced Team Members
18,000
Participants in the past 5 years
26
Years of of CRO experience

“Within Asia-Pacific’s highly competitive CRO market, Avance Clinical stands out as a leader in early phase biotech clinical trials.

The company offers a highly responsive and proactive service for biotechs wanting rapid and innovative clinical trial solutions, with the highest level of data compliance. Avance Clinical offers a real size match for biotechs that means better mission understandings and stronger customer service compared to some of the larger CROs.”

Nidhi JalaliAnalyst Best Practices, Frost & Sullivan

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