In this visual podcast we explore why Australia is an attractive destination for early-phase clinical trials, highlighting the benefits of speed, quality, and cost-effectiveness.
The expert panel discussion delves into Australia’s unique regulatory pathways, the R&D tax incentives, operational logistics, and how early-phase data supports global drug development.
Key Takeaways
- Faster Trial Initiation: Australia’s streamlined Clinical Trial Notification (CTN) pathway allows trials to start 3-6 months faster than in many other regions.
- R&D Tax Incentives: Companies can claim up to 43.5% of eligible R&D expenditure through Australia’s generous tax incentive programs.
- Regulatory Flexibility: Conduct trials without an IND and leverage pragmatic regulatory requirements to accelerate progress.
- Global Data Utilization: Early-phase trial data from Australia aligns with international standards (GCP/ICH), supporting global submissions, including FDA applications.
What You Will Learn
By watching this podcast, you will gain insights into:
- The strategic advantages of conducting clinical trials in Australia, including faster timelines and cost savings.
- How to navigate Australia’s regulatory landscape, including key differences between HREC and IND requirements.
- Practical tips for setting up operations in Australia and maximizing R&D tax incentives.
- Best practices for planning and collaboration to ensure seamless execution of your clinical trial.
- How Australian clinical data can be leveraged for global drug development efforts, particularly for FDA submissions.
Watch the podcast today
Please enter the required details to watch the podcast.
About Resolian
Our footprint includes five sites on four continents. It starts with our headquarters near Philadelphia, Pennsylvania, includes two labs in the UK, a lab in Chongqing, China, and Brisbane, Australia. Our areas of expertise include bioanalysis for all drug modalities, from conventional small molecules, monoclonal antibodies, peptides, oligonucleotides, and complex biologics like ADCs, AOCs, and biospecific antibodies.
Our lab in Australia is purpose built and designed to support phase one clinical trials. We’ve got an emphasis on speed, quality, and cost effectiveness there in Brisbane.
The team has extensive experience using mass spectrometry, immunoassay platforms to support PK, biomarkers, and immunogenicity. We also provide sample kits, lab manuals, and can provide PK analysis for our partners as well.
