Why Choose Australia
By leveraging our local advantages, outsourcing early-phase clinical trials to Australia offers a compelling proposition for sponsors, combining cost-efficiency, speed, and quality outcomes.
Overview
Cost-efficiency
Australia provides cost advantages for sponsors through attractive research and development (R&D) tax incentives. The government offers cash rebates and tax incentives that reduce the financial burden associated with conducting clinical trials, making it a cost-effective option for sponsors.
Speed
The Australian clinical trial process is known for its efficiency and flexibility without compromising quality. By avoiding duplication of processes and implementing streamlined regulatory procedures, sponsors save valuable time and resources. This accelerated timeline enables faster study initiation and data collection, expediting the overall trial timeline.
Quality
Australia boasts a robust research infrastructure, including a vast network of universities, independent medical research institutes, clinical trial networks, biobanks, and contract research organizations (CROs). The scientific research conducted in Australia ranks highly in terms of productivity and impact within the Asia-Pacific region. Additionally, Australia has one of the most rigorous patent protection systems globally, ensuring the security and integrity of intellectual property. Data generated from clinical trials conducted in Australia holds substantial weight and can be utilized to support international regulatory applications, including submissions to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
No IND required
In Australia, there is no mandatory IND application process for early-phase clinical trials. This means that sponsors can initiate their trials without the need to submit an IND application to regulatory authorities. This streamlined process reduces administrative burden and allows for faster trial initiation, enabling sponsors to expedite their research timelines.
GMP Flexibility
Unlike later phases of clinical trials, early-phase trials in Australia do not require investigational products to be manufactured under full GMP standards. Instead, a more flexible approach is adopted, allowing sponsors to produce and supply investigational products with appropriate quality control measures. This flexibility reduces the manufacturing complexities and associated costs, making Australia an attractive choice for early-phase trials.