Run your trial in Australia and skip the delays, red tape, and overhead

Why sponsors choose Australia

Australia offers a powerful combination of speed, savings, and regulatory clarity. It’s one of the most efficient regions in the world for early phase trials.

30-50% cost savings

Running a clinical trial in Australia typically costs around 30% less than in the US or Europe. When paired with the government rebate, the total cost savings can exceed 50%.

43.5% tax rebate

Companies with less than AUD20 million in annual turnover can claim a 43.5% cash rebate on eligible trial costs. This incentive gives you real money back to reinvest in your pipeline.

You can start a clinical trial in Australia without waiting for US FDA IND approval. Studies can begin earlier, often by several months, and the data can still support future IND submissions.

No IND required

How trials start in Australia

Australia offers one of the most streamlined regulatory pathways for early phase trials. Here’s what it takes to get started:

Ethics approval

Submit your protocol to a Human Research Ethics Committee. Most reviews are completed in 4 to 8 weeks. You can begin preparing sites and documents at the same time.

Notify the TGA

After HREC approval, submit a Clinical Trial Notification to the Therapeutic Goods Administration. There is no additional review, only a formal notification and fee.

Once site approvals are in place, your study can start. IND clearance is not required to begin dosing in Australia. Data from these studies can support future FDA or EMA submissions.

Begin your study

Frequently asked questions

Do I need a local sponsor or entity to run a clinical trial in Australia?

Yes, a local Australian sponsor or legal representative is required. Freelance Clinical can help you fulfill this role and navigate local governance with the right partners.

Can I start a clinical trial in Australia without FDA IND approval?

Yes. You can start a Phase I trial in Australia before IND approval. This allows you to generate early data that can later support your FDA submission.

How long does it take to start a clinical trial in Australia?

Most trials start within 8 to 12 weeks. Ethics approval typically takes 4 to 8 weeks, followed by TGA notification and site approvals which can run in parallel.

Is the 43.5% R&D tax incentive available to international companies?

Yes, if you set up an Australian entity and meet eligibility criteria, you can access the rebate. We can guide you through the setup and help assess your eligibility.

Are clinical trial costs lower in Australia compared to the US?

Yes. Costs are typically 30 percent lower. With the R&D rebate, total savings can exceed 50 percent. Flexible models like pay-as-you-go help reduce overhead further.

Will data from Australian trials be accepted by the FDA and EMA?

Yes. Data from Australian trials is accepted by both agencies. Many sponsors begin Phase I in Australia before IND approval and use that data to support global submissions.

We’re here to help

Have questions or need more information? Reach out, and we’ll get back to you within one (1) business day.

Email

info@freelanceclinical.com

Address

Suite 2 Level 1, 9-11 Grosvenor Street

Neutral Bay, NSW 2089 Australia