Benefits of Australia

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