On July 21, 2025, Qualtech hosted a webinar titled "Accelerating Innovation: Why Australia Is the Ideal Partner for Your Next Clinical Trial". The session featured expert speaker Mr. Stefan Czyniewski, Co-Founder and Clinical Director of Mobius Medical, a CRO operating in Australia, New Zealand, and the United States. With a deep understanding of early-phase trials and international regulatory strategies, Mr. Czyniewski delivered valuable insights on Australia's advantages as a destination for clinical trials, particularly for medical devices and diagnostics. This summary highlights the key takeaways and strategic considerations for companies planning global clinical research.
Key Advantages of Conducting Clinical Trials in Australia
- Speed & Cost Efficiency: Australia offers faster start-up timelines and more cost-effective clinical trials compared to the US and EU.
- World-Class Infrastructure: The country hosts highly trained investigators, globally accredited hospitals, and advanced research capabilities.
- Global Recognition of Data: Clinical trial data generated in Australia is widely accepted by international regulatory authorities, including the US FDA, EU MDR, and TGA.
- Government Incentives: The Australian government provides an R&D Tax Incentive, offering substantial rebates on eligible clinical trial expenditures—making Australia financially attractive for early-phase research.
Clinical Trial Start-Up & Approval Steps in Australia
In Australia, clinical trials are conducted under the Clinical Trial Notification (CTN) Scheme, which is designed for speed and simplicity. Here's an overview of the step-by-step process:
- 1. Study Design and Preparation
- The sponsor designs the protocol and prepares essential documentation, including the investigator brochure, informed consent forms, and risk management plan.
- 2. Ethics Approval (HREC)
- Submit the trial protocol to a Human Research Ethics Committee (HREC) for ethical review.
- Timeline: ~2 to 8 weeks.
- 3. Clinical Trial Notification (CTN) Submission to TGA
- Once ethics approval is granted, the sponsor submits a CTN to the Therapeutic Goods Administration (TGA).
- Timeline: 1 to 3 business days.
- 4. Site Governance and Authorization
- Each participating site reviews local requirements, indemnity, and agreements.
- Timeline: ~2 to 4 weeks.
- 5. Patient Recruitment Begins
- Once sites are approved, the sponsor may begin enrolling patients.
Australia vs. USA: Clinical Trial Cost and Timeline Comparison
Comparison between Clinical trial in Australia and the United States, revealing significant strategic advantages:
| Category | Australia (via CTN Scheme) | United States (via IND/IDE Process) |
|---|---|---|
|
TGA (Therapeutic Goods Administration) | FDA (Food and Drug Administration) |
| Ethics Review | HREC (Human Research Ethics Committee) | IRB (Institutional Review Board – site-specific) |
| Main Application Type | Clinical Trial Notification (CTN) – Notification only, no formal review | IND/IDE – Formal FDA review (30+ days) required |
| Timeline – Ethics Approval | 2–8 weeks | 1–6 weeks (varies by site) |
| Timeline – Regulatory Approval | 1–3 days (simple CTN form submission) | 30 days for FDA IDE/IND review |
| Site Governance / Contracting | 2–4 weeks, often standardized & faster | 4–12+ weeks due to individual site budgets and legal review |
| Total Start-Up Time | 2 to 4 months (from HREC to patient recruitment) | 6 to 9 months (FDA + IRB + site readiness) |
| Preclinical Requirements | Assumed completed, not submitted to TGA | Mandatory submission (toxicology, validation, etc.) before IND/IDE |
| Regulatory Complexity | Low – centralized, fast-track process | High – multiple layers of review, site-specific submissions |
| Trial Costs – Medical Devices |
|
Similar cost ranges but 30–60% higher overall due to US overheads |
| Cost Savings in AU |
|
Higher costs for IRB fees, hospitals, investigators, and admin |
| Currency Advantage | Favourable AUD-USD exchange rate | USD basis increases cost for global sponsors |
| Government Incentives | R&D Tax Incentive: up to 43.5% cash rebate on trial costs (local & foreign sponsors) | No federal rebate; limited tax or grant support |
| Example Savings | $2M spend = ~$870K rebate, reusable for next trial phase | No direct financial return on trial spend |
| Other Support |
|
Minimal centralized support for trial startup |
| Use of Data Globally | Accepted by FDA (US), EMA(EU), PMDA (Japan) | Accepted globally |
Overall, Australia offers a faster, simpler, and more cost-effective environment for early-phase clinical trials compared to the United States—making it an ideal strategic choice for companies looking to accelerate development and global approvals.
Australia's Regulatory Pathway and TGA Expectations
The Therapeutic Goods Administration (TGA) is the primary regulatory body overseeing clinical trials for medical devices in Australia. Key points discussed include:
- Clinical trials are not mandatory for all devices, but may be required for novel technologies or products with insufficient clinical evidence.
- For Class II devices (e.g., IV cannulas, three-way stopcocks, IV sets), clinical trials are generally not required if equivalence can be demonstrated, but requirements depend on product claims and risk.
- Clinical trial data from Australia can be used in global submissions, including to support FDA 510(k)/PMA, CE Marking, and other regulatory applications.
- Estimated Clinical Trial Costs and Timelines
- While trial budgets vary based on design and scope, Australia offers competitive pricing relative to the US and Europe. In addition, faster ethics and regulatory approvals help reduce time to first patient-in.
- Leverage Australia as Your Global Launchpad
- The webinar highlighted that Australia is not only an efficient trial destination but also a strategic platform for global market entry. With high-quality data, regulatory recognition, and financial incentives, Australia is especially well-suited for early-phase device trials.
Get Started with Confidence, Partner with Qualtech
Whether you're exploring your first clinical trial or seeking global expansion, Qualtech's regulatory and clinical trial services can help you navigate the complexities of international compliance.
Contact us today to learn how we can support you in Australia and beyond.