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Offices in the San Francisco Bay Area and Sydney, Australia

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