Why run your trial in Australia?
Speed, cost, quality and global acceptability, in one place.
01
Faster study start-up
Australia’s notification-based regulatory scheme and efficient ethics review get trials underway sooner than comparable US or European pathways. For sponsors, that means less time waiting and more time generating data.
02
A meaningful cost advantage
The cash refundable R&D tax offset of up to 43.5%, combined with favourable exchange rates, lower site and operational costs, and significant time savings, materially lowers the net cost of running a study in Australia. A Frost & Sullivan cost comparison put Australia at approximately 28% cheaper than the US before tax incentives, and approximately 60% cheaper after.
Source: Frost & Sullivan, Australia: Preferred Destination for Early Phase Clinical Trials, 2016.
03
World-class infrastructure and people
A highly skilled workforce, a well-established early-phase ecosystem, experienced investigators and reliable recruitment, including healthy volunteer populations. Sponsors also gain access to world-class CDMOs and the specialist services complex studies depend on.
04
Data the world accepts
Australian trials run to ICH GCP, and data generated here is routinely used in FDA, EMA and other global regulatory submissions. Nothing needs repeating.
05
A springboard for global programmes
A culturally and genetically diverse but geographically centralised population makes Australia a natural starting point, with a clear path into later-phase trials across the Asia Pacific and US regions.
Common Questions
Three reasons: speed, cost and data quality. The notification-based CTN scheme starts studies sooner than a US IND pathway, eligible companies can access a refundable R&D tax offset of up to 43.5%, and Australian data runs to ICH GCP and is routinely used in FDA and EMA submissions.
A Frost & Sullivan comparison put Australia at approximately 28% cheaper than the US before tax incentives, and approximately 60% cheaper once the R&D tax offset is applied (Frost & Sullivan, 2016). Actual savings depend on the study and the sponsor’s eligibility.
Not necessarily. An overseas sponsor can conduct a clinical trial in Australia without establishing an Australian entity, provided appropriate local sponsor arrangements are in place. Avion CRO can act as your local sponsor. However, sponsors seeking to access Australia’s R&D Tax Incentive will generally need an Australian-incorporated entity and may establish a local subsidiary for this purpose.
Yes, routinely. Australian trials run to ICH GCP, the same standard the FDA and EMA expect, and data generated in Australia is regularly used in global regulatory submissions.
