Clinical trials

Faster and cheaper clinical trials

Up to 43.5% cashback for clinical trials

Up to 43.5% of R&D costs will be reimbursed in cash to eligible companies with an aggregated annual turnover of less than A$20 million (approx. US$15 million). A substantial tax offset is offered to all other eligible entities.

What’s covered?

Cashback covers all phases of development, from preclinical to Phases 1, 2 and 3. Companies can claim the cost of R&D activities conducted overseas in support of their Australian R&D project, when certain conditions are met. The incentive covers costs including:

  • Clinical trials
  • Analytics
  • Study drug manufacture
  • Other R&D

There is a solid track record of successful claims by companies headquartered overseas, such as the US, when conducting research in Adelaide.

What’s the process?

Before commencing R&D activities, investors interested in benefiting from the financial incentives must set up an Australian company with a local director. There is no requirement to hire full-time employees. A formal agreement with the parent company is required.

The whole process is inexpensive and can take as little as a month. Importantly, all intellectual property remains with the parent company. Consultants with a track record of successful claims are available in Adelaide.

Adelaide’s banking system is available to provide a loan secured against the cashback amount.

The R&D Tax Incentive is an Australian Government initiative jointly managed by AusIndustry and the Australian Taxation Office. For further information please visit www.business.gov.au and www.ato.gov.au.

Ethics approval in an average of 6 weeks

No IND application is required for First in Human clinical trials and Human Research Ethics Committee approval requires an average of only six weeks and is valid in all participating jurisdictions.

This means trials in Adelaide save six to nine months compared to trials in the US or Europe. Ethics submissions consist only of a protocol, investigator brochure and, when required, an independent toxicology report.

Trials in Adelaide are compliant with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). This compliancy means your trials will be compliant with the US Food and Drug Administration, European Medicines Agency, and Japanese and Canadian regulatory bodies.

Local infrastructure and expertise

A one-stop-shop offering smooth transition from preclinical research to clinical trials, Adelaide features:

  • A world-class large animal research facility.
  • One of Australia’s largest and most experienced Phase 1 clinical trials units with a database of more than 13,000 active volunteers.
  • A range of established facilities for Phase 2 and Phase 3 trials.
  • Frequent ethics committee assessment via Australia’s first and largest group of private HRECs (multiple monthly meetings).

Adelaide has a full range of local providers for:

  • Study drug manufacturing.
  • Clinical, data and bioanalytical services for small and large molecule clinical trials.
  • Applied clinical pharmacogenomics (PGx) services.

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Health Industries South Australia is the South Australian Government agency helping life sciences companies expand in Adelaide.