Australian local sponsor for clinical trials.
If your company is planning a clinical trial in Australia, Clintrail can act as the Australian local sponsor.
We work with overseas sponsors that want to run a clinical trial in Australia without setting up their own local entity first.
Clintrail holds the Australian sponsor role and works with your team under a documented responsibility split.
The need
If an overseas company wants to run a clinical trial in Australia, the sponsor role must be held by an Australian entity.What Clintrail does
Clintrail acts as the Australian local sponsor.What stays with you
The overseas company retains product ownership, program leadership, and funding responsibility.Who it's for
Overseas biotech, pharma, medtech, and diagnostics teams planning studies in Australia.Why Clintrail
Why sponsors use Clintrail
Clintrail acts as the Australian local sponsor for overseas companies running studies in Australia, without taking over product ownership or global program control.
Avoid setting up a local company just to sponsor one clinical trial.
Clintrail can hold the Australian sponsor role so your team does not need to incorporate and maintain an Australian entity before the trial begins.
Define who is responsible for what before startup begins.
The local sponsor role should be documented against the responsibilities retained by the overseas sponsor, sites, investigators, and other parties.
Keep product ownership and program leadership offshore.
The overseas company retains product ownership, development strategy, budget control, and the broader global clinical development program.
Role split
What Clintrail covers, and what stays with you.
Clintrail acts as the Australian local sponsor. The overseas company remains responsible for the broader clinical development program.
Clintrail
Acts as the Australian local sponsor for the clinical trial.
Overseas sponsor
Retains product ownership, development strategy, budget, and overall program direction.
This matters to regulatory, legal, clinical operations, and executive teams. It is not enough to appoint an Australian sponsor. The scope of that role also needs to be clear.
Process
How it works
01 - Initial review
We review the clinical trial, sponsor structure, and the planned Australian set-up, then get back to you about the next step.
02 - Role definition
We define what Clintrail will cover as Australian sponsor and what remains with the overseas sponsor.
03 - Ongoing sponsor role
Once appointed, Clintrail remains in place as the Australian sponsor through clinical trial start-up and conduct.
FAQ
Common questions
Can we run an Australian clinical trial without forming a local company?
Yes, where the local sponsor model is suitable. Clintrail can hold the Australian sponsor role so you do not need to incorporate solely to sponsor the clinical trial.
How does Clintrail save time and cost?
It avoids the time, cost, and administration of setting up and maintaining an Australian entity before clinical trial startup.
Why consider Australia in the first place?
Australia offers experienced clinical sites, established review pathways, recognised GCP expectations, and potential R&D tax incentives for eligible activity.
Next step
Need an Australian local sponsor?
Send through a short outline of the clinical trial and your planned Australian activity. We will review it and get back to you soon.