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.
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 24 years
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.