The streamlined clinical trial approvals process in Australia allows your study to be approved in less than 8 weeks without requiring an IND.
The Human Research Ethics Committee (HREC) process takes 4–6 weeks on average. Site governance documents are submitted concurrently and typically take 6-8 weeks.
Clinical Trial Notification (CTN) is the final step in the approvals process. Confirmation from the TGA is usually received within 2–3 days, allowing you to formally commence your study.
The Australian Government offers one of the most generous Research & Development tax incentives in the world, with a potential 43.5% cash refund on every $1 spent for eligible organizations.
Patient, site and labour costs are also significantly lower than in the US, EU and parts of Asia, reducing your funding requirements even further. When combined with a strong foreign currency exchange rate, many of our sponsors can run their studies at less than half the cost of hosting in the USA or other countries.
Additionally, our templated clinical trial agreements reduce uncertainty around trial costs and streamline the negotiation of project budgets.
All Australian clinical trial processes, protocols, and data are FDA, EMA, PMDA and Health Canada-compliant, ensuring your product is ready to launch in your target market. Southern Star’s medical writers are also highly experienced in producing final study reports ensuring easy filing and streamlined approval of submissions to these regulatory bodies.
Our world-class facilities, rigorous patient protection system and renowned scientific experts ensure that data from Australian clinical trials is widely regarded as reliable, accurate and high quality. Our studies have an excellent history of being accepted by international regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), ensuring your product gets to market faster.
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Gordon, NSW, 2072 Australia
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Each member of our Leadership Team boasts an average of 30 years experience. Our clients have access to an extraordinary group of Clinical Research professionals, whose experience covers Multinational Pharmaceutical companies, Biotechnology, Medical Device, CRO’s, research institutes, Universities, Industry Associations & Government Bodies. Together, we ensure that every aspect of your unique and novel drug study clinical trial is handled with scientific precision, care, and foresight.
Our team has all of the tools, knowledge and experience to solve almost any issue that may arise during the complex clinical trial process.
We recognize that each study is unique and different and there are nuances that need to be resolved proactively.
Our advisory board of top-tier specialists in multiple therapeutic areas engage in the early stages from protocol design in constructive discussions to anticipate challenges and enhance study efficiency throughout the study.