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Modern CRO
Support Across
Australia and
New Zealand

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HiRO brings together global discipline and deep ANZ expertise—delivering speed, clarity, and globally accepted data.

HiRO ANZ

CLINICAL EXPERTISE ROOTED IN THE ANZ REGION

Purpose-Built for
Australia and New Zealand

Australia and New Zealand offer one of the most efficient and trusted environments for clinical development, combining rapid startup timelines, experienced investigators, and data recognized by global regulators. HiRO supports sponsors across ANZ with regionally informed execution that enables fast activation, steady oversight, and predictable progress across early-phase and complex studies.

Our teams combine global clinical data science discipline with deep local regulatory and operational understanding. Through consistent communication and regionally aligned execution, we help biotechs anticipate challenges, reduce uncertainty, and make confident decisions grounded in real-time data and proven ANZ performance.

1,500

Studies Conducted Annually Across ANZ

500

Participants Engaged

4-6

Weeks For Typical Start-up Timeline

35

Of All Trials In ANZ Are Early Phase

How We Accelerated Metabolic Study Delivery Across ANZ

See how HiRO supported a Phase II obesity program by applying regionally informed site strategy, disciplined start-up execution, and participant-focused planning across Australia and New Zealand. This case study highlights how ANZ execution can deliver enrollment certainty within complex metabolic studies.

HiRO Whitepaper

Exceeding Recruitment Targets for a Phase II Obesity Trial

Download Case Study
327

Participants enrolled, hitting 101% enrollment rate (327 of 325).

16

Active study sites across the ANZ region.

WHAT SPONSORS GAIN IN ANZ

Regionally Informed,
Globally Linked

HiRO delivers predictable, regionally informed study execution across Australia and New Zealand, supported by global clinical data science discipline and steady operational oversight. Our teams understand the regulatory pathways, site capabilities, and operational nuances that make ANZ an ideal environment for early-phase development and oncology-focused programs.

Through our HiRO LINKAGE™ Approach, regional expertise connects directly with HiRO’s global standards— creating a unified study experience grounded in clarity, continuity, and consistent delivery. Sponsors gain structured communication, evidence-driven guidance, and confidence that every decision is informed by local insight reinforced with global execution strength.

Australia

Australia offers fast startup timelines, diverse patient access, and a clear TGA framework that supports efficient clinical delivery. With strong early phase capability, dependable sites, and globally recognized data, it provides an effective setting for complex studies requiring predictable regulatory oversight.

TGA Alignment

New Zealand

New Zealand offers streamlined HDEC review, committed site partners, and a research culture known for reliable data and steady enrollment. With experienced investigators and timelines that consistently move faster than global averages, it provides a focused, efficient environment for earlyphase development and multi-country study support.

HDEC Efficiency

DISCIPLINE, CLARITY, AND DEPTH

Oncology Expertise Built
For Early-Phase Precision

Oncology studies demand rigor, scientific depth, and calm execution under pressure. HiRO’s oncology teams bring together global experience, regional insight, and biometrics-led precision to guide complex programs with evidence-driven confidence.

Across Australia and New Zealand, streamlined regulatory pathways enable rapid initiation of doseescalation and proof-of-concept studies—often while IND or CTA preparations continue in parallel for larger markets. This efficiency allows sponsors to generate early PK/PD and safety data faster, supporting smarter decisions and milestone-driven development.

Regulatory Efficiency: ANZ offers uniquely efficient pathways for early-phase oncology studies, enabling initiation within weeks rather than months while maintaining robust scientific and ethical oversight.

Capital Efficiency: Australia’s R&D Tax Incentive provides up to 43.5% refundable offsets, supporting extended runway and reinvestment into development.

Clinical Infrastructure: World-class oncology centers, experienced investigators, and English-speaking healthcare systems deliver high-quality data aligned with FDA and EMA expectations.

Strategic Global Positioning: Data generated in ANZ is widely accepted in global submissions, providing a strong foundation for INDs, CTAs, and multi-regional expansion.

Ready To Advance Your Study?
Let’s Explore What’s Possible In ANZ.

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