Study design and site selection
- Clinical research strategy and protocol design support
- Clinical trial site selection, engagement and project communication
- Coordination with hospitals, research teams and stakeholders
Ethics and regulatory preparation
Australian clinical research needs ethics and regulatory pathways assessed against product and study details. CTN/CTA and research ethics review requirements are distinct. Clinical trial Sponsor responsibilities should also be distinguished from product supply Sponsor responsibilities.
- Ethics and applicable regulatory submission support
- Coordination of responsibilities, documents and start-up conditions
- Research site and stakeholder communication
Study operations and data work
- Clinical project management and site coordination
- Data management and statistical analysis support
- Connecting clinical reports with registration evidence
Related submission cases
Explore selected casesFrequently asked questions
Is a CTN submission all that is needed for an Australian clinical study?
CTN is a notification mechanism, not TGA approval of all study data. Applicable projects also require HREC ethics review and institutional authorization. The choice between CTN and CTA depends on product risk, existing evidence and review capability. Before starting, map regulatory, ethics and site documentation and responsibilities, and confirm the protocol, trial product and site readiness. Progress under the authorized protocol once the relevant conditions are met, rather than using notification submission as the sole start milestone.
Official sources:TGA：Australian clinical trial handbook
Checked:
Can you guarantee recruitment speed or research results?
Recruitment planning depends on feasibility evidence about the protocol, eligibility criteria, site capability and accessible population; study results depend on the data. Plan site activation, screening, enrolment, follow-up and data cleaning separately, with assumptions for each stage. Agree progress tracking, issue reporting and adjustment procedures rather than promising efficacy or a fixed recruitment rate to match a launch date. A specific feasibility assessment supports a more workable budget and schedule.
What should we prepare for an initial clinical project discussion?
Begin feasibility with the question the study must answer rather than the number of sites or participants. Prepare intended use, development stage, existing nonclinical and clinical evidence, the proposed population, main endpoints and trial-product supply arrangements. Identify unresolved matters and decisions dependent on further evidence before discussing protocol and budget. This separates research foundations that need work from ethics, regulatory and site discussions that are ready to progress.
Official references
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.
