We support Phase I through Phase IV trials. Our GP clinic network is particularly well-suited to Phase II and III studies in common chronic conditions, while our specialist collaborator network can support selected Phase I studies and oncology protocols. Contact us to discuss the specific requirements of your program.
Timeline depends on the HREC review cycle and institutional sign-off requirements. With the NHMRC Single Ethical Review framework, approval covers all network sites under one submission. Once ethics approval is in place, site activation typically proceeds in four to eight weeks, depending on sponsor contract execution and site readiness. We will provide a realistic timeline estimate during the feasibility phase.
Yes. We regularly work with sponsors based in the United States, Europe, and Asia-Pacific who want to include an Australian cohort in a global trial or run an Australia-only study. We understand the requirements of the TGA CTN pathway and can coordinate regulatory submissions on your behalf. All data we generate meets ICH-GCP requirements for international regulatory submissions.
Yes. We will review your protocol and provide a preliminary feasibility assessment at no cost and without commitment. This includes an assessment of patient population availability, site capability, and indicative enrolment timelines. We prefer to do this early in your planning process so you can make an informed decision about including Australia in your program.
For Clinical Sites
We work with GP practices and small hospital departments that have an interested principal investigator, stable patient populations relevant to our therapeutic areas, and adequate consultation space for study visits. We do not require existing research experience. That is exactly what we provide through our training and coordination support.
The investigator's time commitment varies significantly by protocol. For many Phase II/III studies in stable chronic conditions, the PI's direct involvement is primarily in consent discussions, clinical assessments at specified visits, and adverse event review. Much of the day-to-day coordination is handled by our study coordinator. We will give you an honest estimate of the time commitment during feasibility discussions.
We prepare all regulatory submissions, including TGA CTN notifications, HREC application materials, and institutional governance documents. The PI reviews and signs as required under the regulations, but the preparation and coordination is handled by our central team. We also maintain the site's essential document file on an ongoing basis.
For Patients
The best starting point is to speak with your GP. If you believe you may have a condition that is relevant to one of our therapeutic areas, your GP can refer you to one of our sites for a screening assessment. You can also contact us directly through our contact page and we will help direct you to the right person.
There is generally no cost for participating in a clinical trial. The investigational treatment is provided at no charge. In many trials, participant expenses such as travel to study visits may be reimbursed. This will be explained in the Participant Information Sheet before you consent to anything.
Regulatory & Quality
The Clinical Trial Notification (CTN) scheme is the primary pathway for conducting clinical trials in Australia. Under this scheme, the sponsor notifies the TGA of the trial rather than seeking TGA approval of the trial itself. The TGA has 28 days to object before the trial may begin. This scheme is used for the vast majority of industry-sponsored trials in Australia and allows faster trial initiation compared to the older CTX (Clinical Trial Exemption) scheme.
The NHMRC Single Ethical Review (SER) framework, introduced in 2018, allows one accredited HREC to provide ethical approval for a multi-site study without requiring separate ethics submissions at each site. Each participating institution still provides institutional governance sign-off, but the ethics review is centralised. This significantly reduces administrative burden and approval timelines for network studies.
Still Have Questions?
We can answer questions about your specific situation, whether you are a sponsor, a potential site, or a patient.