Why run a clinical trial in Australia?

Australia offers a streamlined regulatory pathway through the Clinical Trial Notification (CTN) scheme, internationally accepted data, an R&D Tax Incentive of up to 43.5% on qualifying expenditure, and experienced ICH-GCP investigators. Trials can typically commence within 6 to 8 weeks of ethics submission.

What is the TGA CTN scheme?

The Clinical Trial Notification scheme is Australia's primary regulatory pathway for clinical trials of unapproved therapeutic goods. Under CTN, the Therapeutic Goods Administration is notified after Human Research Ethics Committee approval, rather than evaluating a preclinical data package as required by the FDA's IND process. This typically shortens time to first patient dosed.

Does Australian clinical trial data get accepted by the FDA?

Yes. Clinical data generated in Australia is accepted by the FDA and the European Medicines Agency. Australian trials adhere to ICH-GCP guidelines and are subject to TGA inspection, which means data quality meets international standards required for downstream regulatory submissions.

Who is the R&D Tax Incentive for?

The Australian Government's R&D Tax Incentive provides eligible companies with a refundable tax offset of up to 43.5% on qualifying R&D expenditure, including clinical trial costs. For companies with aggregated turnover below AUD $20 million, this is paid as a direct cash refund, which is particularly valuable for pre-revenue biotechs.

What does Scalable Trials actually do?

Scalable Trials provides clinical trial consulting for biotechs entering Australia. Engagements cover Australian market entry strategy, TGA and HREC submissions, drug importation, partner and site activation, owned-site development, trial optimisation, and AI-accelerated documentation. Founder Dr. Glenn Fitzpatrick has scaled Australian clinical operations from zero to fully operational for a US biotech.

What are New Approach Methodologies (NAMs) in clinical trials?

New Approach Methodologies are non-animal alternatives used in preclinical drug development, including in-vitro human-based systems, in-silico computational modelling, and organ-on-chip microphysiological platforms. Australian HRECs such as Bellberry have been early adopters of NAM-enabled trial protocols, and the FDA Modernization Act 2.0 formally authorised these methods in the United States.

Scalable.

Navigate Australian Clinical Trials.

Explore My Approach Consultation

Scale Faster. Enter Markets Smarter.

Built From Real Experience. Scalable Trials comes from direct experience scaling Australian clinical operations from zero to fully operational for a US biotech. End-to-end trial execution expertise that accelerates your market entry.

What I Bring. Regulatory approvals, clinical sites, drug importation, hospital partnerships. I identify inefficiencies in your operations and help you make significant savings.

Scale With Agility. Access established networks across Australian regulators, healthcare systems, and clinical operations without the burden of permanent headcount. Ramp up for trial execution, scale down between studies.

Scalable Trials

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"I've scaled clinical operations in Australia from zero to fully operational at a fraction of what conventional outsourcing models quote. Most sponsors accept those costs as the price of entry. I knew there had to be a better way. The right strategy, the right connections, and a delivery model that doesn't require you to overspend to move fast."

Dr. Glenn Fitzpatrick Founder, Scalable Trials

Navigate Australian Clinical Trials.

Currently accepting new engagements for Q3 2026.

Regulatory Expertise

TGA, HREC, Drug Import

Established Networks

Sites, CROs, SMOs

Flexible Engagement

Hourly or Project-Based

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Australian clinical trials made simple.

Backlog 3

Discovery

Initial consultation & market assessment

Due: 15 Mar 2026

Assessment

Regulatory landscape analysis

Due: 22 Mar 2026

Analysis

Cost-benefit analysis of partner options

Due: 30 Mar 2026

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Ready to Start 2

Strategy

Delivery model aligned to your objectives

Due: 01 Apr 2026

Planning

Partner & site selection

Due: 05 Apr 2026

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In Progress 2

Execution

Site activation & regulatory setup

🟢 65%

Oversight

Trial delivery management

🟡 40%

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Completed 1

Success

Trial delivered successfully

✅ Complete

ALL

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Australia's First NAM-Enabled FIH Trial: A Case Study

Case Study

Research-Led Consulting

From the bench to bedside. Bringing peer-reviewed science and hands-on trial experience to every engagement.

Frontiers

Human endothelial cell-derived exosomal microRNA-99a/b drives a sustained inflammatory response during sepsis by inhibiting mTOR expression

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Scientific Reports (Nature)

Intra-vital imaging of mesenchymal stromal cell kinetics in the pulmonary vasculature during infection

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Frontiers in Immunology

Early Host Interactions That Drive the Dysregulated Response in Sepsis

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Seminars in Thromb. & Hemostasis

The Evolving Role of MicroRNAs in Endothelial Cell Dysfunction in Response to Infection

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Frontiers

Human endothelial cell-derived exosomal microRNA-99a/b drives a sustained inflammatory response during sepsis by inhibiting mTOR expression

View Paper →

Scientific Reports (Nature)

Intra-vital imaging of mesenchymal stromal cell kinetics in the pulmonary vasculature during infection

View Paper →

Frontiers in Immunology

Early Host Interactions That Drive the Dysregulated Response in Sepsis

View Paper →

Seminars in Thromb. & Hemostasis

The Evolving Role of MicroRNAs in Endothelial Cell Dysfunction in Response to Infection

View Paper →