Australian Research Opportunities

Here at Genesis Research Services, we are proud to work with medical device and pharmaceutical companies from around the world to bring a range of clinical trial opportunities to Australia. We are always looking to partner with new sponsors and clinical research organisations and value our repeat partnerships. 

We encourage more international sponsors to consider the following advantages of conducting trials here in Australia.

With a highly trained medical research workforce and adherence to internationally recognised Good Clinical Practice (ICH-GCP) guidelines and standards for the conduct of clinical trials, Australia has an excellent reputation when it comes to the quality and reliability of its data and the safety of its clinical research. Because of this, Australian clinical trial data can be used to support applications to international regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Read more about clinical trial regulation in Australia here.

In Australia, all clinical trials must be approved by a Human Research Ethics Committee (HREC) to ensure that the trial conforms to the ethical guidelines, standards, laws and regulations set forth in the National Statement. This typically takes around 4-8 weeks.

If the trial involves the use of an unapproved therapeutic good, it is also subject to regulation by the Therapeutic Goods Administration (TGA) under one of two schemes:

  1. CTN – Clinical Trial Notification – the sponsor must complete an online form to notify the TGA of the intention to conduct a trial. The TGA does not review any pre-trial data. The HREC reviews all material prior to approval.
  2. CTA – Clinical Trial Authorisation – the sponsor must submit a formal application and supply scientific/preclinical data for evaluation. The TGA reviews the data and grants approval for the proposed trial. HREC approval is also required. This is generally required for more novel or high-risk treatments.

The CTN route is a simple, quick process and avoids the high costs associated with preparing a full regulatory application.

Australia has also developed a National Certification Scheme for ethical review of multi-centre research to reduce unnecessary duplication of HREC applications.

The Australian Government is focused on encouraging clinical trials in Australia through funding and tax incentives.

Funding initiatives include:

The Australian Government also established the Research & Development (R&D) Tax Incentive, allowing companies conducting eligible R&D activities to claim refundable or non-refundable R&D tax offsets (depending on their aggregated turnover).

Opportunities for international sponsors to conduct clinical trials in Australia - Genesis Research Services Newcastle

Contact us to learn more