Australia suits clinical trials for sponsors from Asia, from first-in-human studies through later phases. Sponsors notify the TGA under the Clinical Trial Notification (CTN) scheme, and an ethics committee approves the protocol. The TGA does not review the data package before the study starts.
Why Australia
Asian sponsors went from 6% to 39% of Australian Phase 1 oncology trials between 2012 and 2022 (Hitchen et al., Asia-Pacific Journal of Clinical Oncology, 2024).
Dedicated trial units, hospital co-location and a notification pathway give sponsors clean human safety data in months.
What Lotus Health Does
- Sponsor qualification: confirms the asset, stage and budget fit Australian clinical trial delivery.
- Australian entity set-up: introduces the advisers who establish the local subsidiary.
- Trial site and CRO matching: brings qualified programmes to sites and CROs with capacity.
- Sponsor coordination: Lotus Health manages the sponsor so trial sites and advisers have less work.
How It Works
The sponsor appoints an Australian entity. A trial site or CRO runs the study, and the entity lodges the CTN after ethics approval.
R&D Tax Incentive
Eligible Australian R&D can attract a refundable offset of 43.5% for companies with group aggregated turnover under A$20M. The test counts the foreign parent’s worldwide revenue, so eligibility depends on group structure. Lotus Health works with specialist R&D tax advisers and does not give tax advice.
Next Step
Contact Lotus Health to discuss a programme.