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Early Phase Trials - The Australian Advantage

The Most Attractive Place in the World for Clinical Trials

Avance Clinical: Early Phase Specialists With Over 25 Years of Experience

Avance Clinical is a full service CRO with deep scientific knowledge and experience across a broad range of therapeutic indications. We are cell and gene-therapy accredited (with the OGTR in Australia) and are the leading early-phase specialists. The benefits of working with Avance Clinical include:

  • Leveraging our experience for your success
  • Emphasis on right patients, right sites
  • A high-touch approach with a quality focus
  • Dedicated biotech CRO which does not prioritize larger clients over other customers
  • A trusted CRO partner for biotechs
  • Access the ClinicReady and GlobalReady services

The Australian Advantage: Save Time and Up to 43.5% on Clinical Trial Spend

The Australian Regulatory Framework is the fastest in the world for early phase clinical trials. Access the Avance and Australian Advantage which offers rapid start up, levering up to 43.5% rebates to reduce costs, delivering internationally accepted quality data from world-leading clinical settings, KOLs and PIs.

The benefits include:

  • Deep scientific expertise through ClinicReady services, to support translational pathway from pre-clinical to Phase I
  • No IND required
  • Rapid IR/EC approval – 5-6 week start-up
  • World-class, globally accepted data for FDA
  • Extensive site network in Australia & New Zealand

GlobalReady by Avance Clinical

GlobalReady enables biotechs worldwide to conduct their early phase trials in Australia and seamlessly transition to the US for later phase trials, all with the one CRO. 

This provides the following benefits:

  • Reduce start-up time to 5-6 weeks 
  • Centralized data and reporting
  • Access to a diverse patient pool 
  • Access to world-class data, KOLs, and extensive site networks across Australia, New Zealand and United States, engaged with > 1,500 sites and >300 KOLs globally
  • High quality data that is globally accepted
  • Save up to nine months on a clinical program with GlobalReady
  • Established global Scientific Advisory Board

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, specialized 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
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

Request a Proposal or Talk to our Team  CONTACT US

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

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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