Case Study Background:
A Sponsor, based in the United States, was interested in conducting a clinical trial in Australia due to the following benefits:
- R&D tax incentive program
- Cost-effectiveness
- Accelerated timelines
- Quick regulatory pathway
Since the Sponsor did not have an Australian subsidiary, they utilized InClin PTY LTD to help them establish a local presence and to conduct their clinical trial.
InClin’s Approach:
- Set-up local subsidiary on behalf of the Sponsor to take advantage of the Australia R&D tax incentive program
- Leverage InClin’s existing relationships with Phase 1 units to accelerate study Start-Up activities and HREC approvals and study timelines
- Conduct the trial; provide personnel and services in Australia to maximize the R&D tax incentive benefit
InClin’s Actions Taken:
- Served as local regional Director
- Assisted the Sponsor in identifying and sourcing an in-country accounting group
- Assigned local resources to allow the Sponsor to maximize the financial benefits they could obtain under the Australian R&D tax incentive program
- InClin regionally managed the project from study start-up to end
- Submitted the Therapeutic Goods Administration’s (TGA) Clinical Trial Notification (CTN) and the Australian New Zealand Clinical Trials Registry (ANZCTR) on behalf of Sponsor
InClin Results:
- The clinical trial was successfully conducted
- Sponsor recovered ~45% of the study cost through the Australia’s R&D tax incentive program
- Shaved approximately 2 months off the timeline of the study