We provide pharmaceutical sponsors and CROs with access to a qualified, audit-ready investigator network across Australia, covering all trial phases from first-in-human through to post-market research.
A coordinated network approach reduces the complexity of multi-site trials in Australia. We handle the site-side management so your team can focus on the science and the data.
We review your protocol against our site capabilities, patient populations, and therapeutic expertise. You receive a candid assessment before committing to site contracts.
We identify and qualify sites that match your protocol requirements. Site activation includes SIV, delegation logs, regulatory submissions, and staff GCP training.
Our team manages patient identification, screening, and enrolment against your targets. We provide regular progress reporting and escalate issues early.
We coordinate TGA CTN notification, HREC Single Ethical Review submissions, and institutional governance approvals. We have direct experience with the Australian regulatory pathway.
Our quality framework is built to meet ICH-GCP E6 R2 requirements. We support sponsor monitoring visits and maintain audit-ready essential document files at all sites.
Site closeout procedures, essential document archiving, and final reporting are completed to ICH-GCP and sponsor requirements. We retain archived records for the required period.
Australia offers a range of advantages for international sponsors looking to include an Australian cohort or run standalone Australian studies.
The TGA CTN pathway allows trials to begin quickly once HREC approval is in place. Australia has a well-educated, medically engaged population, relatively low background medication rates in some therapeutic areas, and experienced investigators with international trial exposure.
The Research and Development Tax Incentive (R&DTI) scheme may also provide financial benefits for sponsors conducting eligible research in Australia. We can connect sponsors with advisers who specialise in this area.
NHMRC Single Ethical Review covers all network sites under one HREC submission, removing the need for site-by-site ethics applications.
Australia is an ICH member country. Data generated here meets ICH-GCP requirements and is acceptable for international regulatory submissions.
Our network in community settings reaches patient populations that hospital-based recruitment often misses, particularly in suburban and regional areas.
Share your protocol information with us and we will provide an honest assessment within two business days.