Clinical trial software for studies in Australia
Australia is a popular place to start clinical development: a notification scheme that can get early-phase trials running quickly, experienced research units and strong ethics review. Capture runs Australian sites in the same study as the rest of your programme.
- Early-phase friendly
- One study across regions
- No per-site fee
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Australia
- Regulator
- Therapeutic Goods Administration (TGA)
- Schemes
- CTN notification or CTA approval
- Ethics
- Human Research Ethics Committees (HRECs)
- Data protection
- Privacy Act 1988 and state laws
- Hosting options
- EU (Frankfurt) or US (N. Virginia)
Key points for studies in Australia
- Trials of unapproved therapeutic goods run under one of two TGA schemes: the Clinical Trial Notification (CTN) scheme, where the sponsor notifies the TGA after ethics approval, or the Clinical Trial Approval (CTA) scheme, where the TGA evaluates the application first. Most trials use the CTN scheme.
- Scientific and ethical review is done by a Human Research Ethics Committee (HREC); national mutual acceptance arrangements allow a single review for multi-site studies in participating states.
- Personal information is governed by the Privacy Act 1988 and the Australian Privacy Principles, plus state health records laws in some states.
- Australia is widely used for first-in-human and early-phase trials, helped by the CTN scheme and research and development tax incentives for eligible companies.
- Trials should be registered, commonly in the Australian New Zealand Clinical Trials Registry (ANZCTR) or another primary registry.
Research landscape
Why many programmes start in Australia
Under the CTN scheme, the TGA does not evaluate the trial before it starts; the HREC reviews it and the sponsor notifies the TGA. Combined with experienced Phase 1 units and eligibility for tax incentives on local research spending, that makes Australia a common choice for first-in-human studies by biotechs from the US, Europe and Asia. Data from Australian early-phase trials is then used to support applications elsewhere, which is why it needs to be collected to international standards.
That means the same controls you would use anywhere: locked forms, edit checks, a field-level audit trail and electronic signatures, so the Phase 1 dataset stands up when a US or European regulator reviews it. See EDC for Phase 1 clinical trials.
Privacy and overseas hosting
Australian Privacy Principle 8 deals with disclosure of personal information overseas. Keep identifying information at the site and use coded participant IDs for sponsor-side users, which Capture does by design, and document the hosting region and contractual protections in your privacy assessment and participant information.
Early phase
Dense early-phase schedules without the build delay
Upload the protocol and the AI Study Generator drafts visits, windows and forms for review. Calculated fields such as BMI, QTcF and eGFR are shown during entry, and sentinel dosing and cohort schedules sit in one study with one audit trail.
- AI-drafted visits and forms from the protocol.
- Calculated fields for common safety values.
- Free sandbox to test before HREC submission.
Build a first-in-human schedule
Upload a protocol to the free sandbox and review the draft.
Schemes
CTN and CTA at a glance
| CTN scheme | CTA scheme | |
|---|---|---|
| TGA role | Notified; does not evaluate the protocol before the trial starts | Evaluates the application before approval |
| Ethics | HREC reviews and approves | HREC reviews and approves |
| Typical use | Most trials, including many first-in-human studies | Higher-risk products or where the HREC lacks the expertise to assess safety |
| Timeline driver | HREC and site governance review | TGA evaluation plus HREC review |
Check current TGA guidance for your product type. Site-specific governance approval is also needed at each institution.
Trans-Tasman
Australia and New Zealand together
Many programmes run sites in both Australia and New Zealand. The Australian New Zealand Clinical Trials Registry covers both countries, but New Zealand has its own regulator (Medsafe) and ethics committees, so approvals are separate. Planning both countries together can add sites and participants without much extra coordination.
In the data system, both countries are simply sites in the same study, with the same forms and checks. Keep country-specific consent versions and approvals tracked per site, and use the country filter on the dashboard to compare enrolment. See clinical trial study start-up software.
Before you start
Australia study set-up checklist
Scheme chosen
CTN or CTA, based on product and risk.
HREC approval
Single review under national mutual acceptance where available.
Site governance
Research governance authorisation at each institution.
Privacy assessment
Overseas disclosure and hosting documented.
Registry entry
ANZCTR or another primary registry.
Site activated
Ethics approval, contract, initiation visit and delegation log.
Can New Zealand sites join the same study?
Yes. New Zealand approvals are separate, but sites run in the same study with the same forms.
Which registry covers Australia?
The Australian New Zealand Clinical Trials Registry is commonly used for both countries.
Who regulates clinical trials in Australia?
The Therapeutic Goods Administration (TGA), through the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.
What is the CTN scheme?
A notification scheme in which an HREC reviews the trial and the sponsor notifies the TGA, without a TGA evaluation of the protocol before the trial starts.
Why do biotechs run Phase 1 trials in Australia?
The CTN scheme, experienced early-phase units and tax incentives for eligible research spending make Australia a common starting point.
Can Australian sites join a global study in Capture?
Yes. Every site runs in the same study with the same forms, checks and audit trail.
Where is data hosted for studies in Australia?
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Assess the cross-border transfer rules that apply to your study before choosing.
Can I try it before committing?
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
Related pages
EDC for Phase 1 trials
Early-phase data capture.
EDC for first-in-human studies
FIH schedules and safety.
Clinical trial software Singapore
Asia-Pacific hub.
Clinical trial software Japan
Another Asia-Pacific guide.
Multi-site clinical trial management
Sites across countries.
IRB and ethics committees
Ethics review explained.
Start your programme in Australia
Trial-grade controls from the first participant. Free sandbox.