AUSTRALIAN
Clinical trials
Australia is the country of choice for international biotechnology, medical device and pharmaceutical sponsors wishing to accelerate their clinical development programs and reduce their funding requirements.
Conducting your clinical trials in Australia has many benefits, including:
- A streamlined approvals process, resulting in as short as a 4-8 week timeline from submission to site initiation
- A favourable regulatory framework - no need to lodge an Investigational New Drug (IND) application
- Generous cost savings and tax incentives – potentially up to 60% less than the US, EU and other major jurisdictions
- World-class facilities, medical infrastructure and talent, resulting in data accepted by the FDA, EMA and other regulators
Clinical trial approvals process
The streamlined clinical trial approvals process in Australia allows your study to be approved in less than 8 weeks and avoid an IND.
The Human Research Ethics Committee (HREC) process takes 4–6 weeks on average. Site governance documents are submitted concurrently and typically take 6-8 weeks.
Clinical Trial Notification (CTN) is the final step in the approvals process. Confirmation from the TGA is usually received within 2–3 days, allowing you to formally commence your study.
R&D tax incentives and trial costs
The Australian Government offers one of the most generous Research & Development tax incentives in the world, with up to a 43.5c cash rebate for every $1 spent for eligible organisations.
Patient, site and labour costs are also significantly lower than the US, EU and parts of Asia, reducing your funding requirements even further. Additionally, templated clinical trial agreements reduce uncertainty around trial costs and streamline the negotiation of project budgets.
Clinical trial environment
Our world-class facilities, rigorous patient protection system and renowned scientific experts ensure that data from Australian clinical trials is widely regarded as reliable, accurate and high quality. Studies have an excellent history of being accepted by international regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).