Process
How local sponsorship works
The aim is straightforward: put the Australian sponsor role in place, define responsibilities clearly, and support the study through start-up and conduct.
Operating sequence
The process
Overseas sponsors need to know whether Clintrail can act as the Australian sponsor, what that role will cover, and how the study team will work with it in practice.
Initial call and sponsor assessment
Clintrail reviews the sponsor structure, product type, planned Australian footprint, likely CTN (Clinical Trial Notification) or CTA (Clinical Trial Approval) pathway, sites, timing, and local sponsor requirements.
Sponsor responsibility matrix
The Australian sponsor role is mapped against responsibilities retained by the overseas sponsor, sites, investigators, and other parties, including safety reporting, records, insurance, and governance inputs.
Sponsor agreement and site contracts
Clintrail enters into the sponsor agreement and executes contracts with Australian investigational sites. The pathway, insurance, indemnity, and startup sequence are confirmed as part of the operating model.
Ongoing sponsor oversight
Clintrail remains in place as the Australian sponsor during study conduct, manages sponsor communications with the TGA, handles required notifications, and oversees Australian safety reporting responsibilities.
Role logic
Responsibilities need to be clear before startup begins.
What Clintrail is engaged to do
Act as the Australian sponsor, manage TGA-facing sponsor communications, handle required notifications and safety reporting, and execute contracts with Australian investigational sites.
What remains with the overseas sponsor
Product ownership, development strategy, global program decisions, and the work that sits outside the Australian local sponsor role.
Why this matters
The Australian study should not be built around unclear sponsor responsibilities. The sponsor structure needs to be settled before key startup decisions are made.
Typical questions
What this process clarifies early
How should the Australian sponsor role be structured?
Not every program has the same Australian sponsor requirements, so the first question is how the Australian sponsor role should be structured.
What exactly will the Australian sponsor role cover?
The split is defined up front so the trial team knows what Clintrail will cover as Australian sponsor and what remains with the overseas sponsor.
How does the role carry into startup and study conduct?
The sponsor role needs to work once startup begins. That is why the process is built around execution rather than a high-level qualification step.
What we need from you
Useful information for the first discussion
- Sponsor company, country, and proposed Australian structure.
- Product type, development stage, and whether the product is a drug, biologic, medical device, diagnostics or IVD, or other therapeutic good.
- Draft protocol, synopsis, or study outline, if available.
- Expected Australian sites, investigators, patient population, and startup timing.
- Current thinking on CTN (Clinical Trial Notification) or CTA (Clinical Trial Approval) pathway, safety reporting, insurance, indemnity, contracts, records, and study governance.
What you get back
Practical outputs from the process
- A focused discussion on how the Australian sponsor role should be structured.
- A draft responsibility split between Clintrail, the overseas sponsor, sites, investigators, and other parties.
- Alignment on the Australian sponsor inputs for CTN or CTA activity, where relevant.
- Clear next steps for the sponsor agreement, site contracts, TGA communications, and the operating model for startup and conduct.
Next step
Talk to us about your study
If your team needs an Australian local sponsor, send through a short outline of the study and your planned Australian activity.