Why Avance Clinical for
Early Phase Clinical Trials
in Australia

Biotechs choose Avance Clinical when they need more than access to Australia – they need a CRO partner that can turn the Australian framework into a faster, more predictable early phase program.

Avance Clinical is a global CRO for biotechs with market-leading Early Phase expertise in Australia and New Zealand. We combine rapid start-up pathways, experienced early phase teams, strong Phase I unit and specialist site networks, and globally accepted data delivery to help sponsors move from First-in-Human to key proof-of-concept milestones with confidence.

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CONTACT OUR IN HOUSE SCIENTIFIC & REGULATORY AFFAIRS TEAM IN AUSTRALIA, NORTH AMERICA AND EUROPE

Delivering more than 30 years experience of drug development expertise

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Why Avance Clinical, Not Just Australia

Australia is a powerful environment for Early Phase trials – but results depend on execution.

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Avance Clinical helps biotechs maximize the Australian Advantage through:

Early phase operational expertise built specifically for biotech programs

In-house global scientific and regulatory affairs support

Proven Phase I unit and site network access

Fast, coordinated start-up and study execution

Data quality accepted by major global regulators

A clear pathway from early phase to global expansion through one CRO partner

Accelerate Study Start-up with a CRO Built for Early Phase

Speed matters in early development – but so does quality.

Avance Clinical is structured to support rapid, high-quality early phase execution in Australia, including:

  • Early phase strategy and study design support
  • Regulatory pathway navigation for Australia, New Zealand, United States, South Korea and Taiwan
  • Start-up coordination across Phase I units, specialist sites, bioanalytical laboratories, vendors, and study teams
  • Tight project management and proactive communication
  • Functional integration across clinical operations, biometrics, Medical writing, and safety

Avance Clinical continues to demonstrate 4 – 5 week start-up timing (Site Initiation Visit and study start) for eligible programs in Australia, helping biotechs get to first patient and early data faster.

Make the Most of Australia’s Regulatory and Cost Advantages

Australia offers a fast and pragmatic clinical trial environment, including the CTN and CTA pathways administered by the TGA.

Avance Clinical helps biotech sponsors navigate these pathways efficiently and align them to global development plans.

For eligible companies, Australia’s R&D Tax Incentive can also materially improve capital efficiency. The program is administered by the Australian Government and provides an R&D tax offset based on company turnover and eligibility of up to 43.5% on eligible spend. Avance supports biotech sponsors in planning studies to optimize program execution in Australia while working alongside their tax and finance advisors on rebate strategy.

Globally Accepted Data,
Delivered for Biotech
Decision-Making

Early Phase is not just about speed – it is about generating decision-grade data that moves a program forward.

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Avance Clinical supports biotechs with:

Quality systems and processes designed for early data decisions and global expectations

Data accepted by major regulatory authorities including FDA, EMA, MHRA, TFDA, MFDS

Cross-functional teams experienced in early phase biotech programs

Scalable support from early phase through later-phase global studies

This gives sponsors confidence that their Early Phase program in Australia can support the next regulatory, clinical, and investor milestones.

Early Phase Center of Excellence for Biotechs

Avance Clinical’s Early Phase Center of Excellence is designed to help biotechs accelerate First-in-Human and proof-of-concept milestones with a more structured, predictable model for early development. Avance positions this capability around deep early phase expertise, global reach, and biotech-focused delivery.

The Early Phase Center of Excellence is built to support:

  • Better early planning and study design decisions
  • Faster execution through integrated teams and proven workflows
  • Stronger operational consistency across studies
  • Clear transition planning into Phase II and global programs

Connect with Liahna Toy, Senior Vice President & Head of Early Phase Center of Excellence

Why Biotech Sponsors Choose Avance Clinical

Avance Clinical combines the advantages of Australia with the capabilities of a biotech-focused global CRO:

  • 30+ years of CRO experience
  • Early Phase market leadership in Australia
  • Global operations across Australia, New Zealand, Asia, North America, and Europe
  • In-house scientific and regulatory affairs
  • Long-standing and strong Phase I unit and site partnership networks
  • ClinicReady and GlobalReady pathways for continuity from preclinical to later phases

For biotech teams under pressure to conserve capital, move quickly, and generate globally usable data, Avance offers a practical path to early phase progress.

Talk to Avance Clinical About Your Early Phase Program

If you are planning a First-in-Human, single and multiple ascending dose (SAD/MAD), food effect (FE), drug-drug interaction (DDI), bioavailability and bioequivalence (BA/BE), or early patient study, Avance Clinical can help you design the right Australian entry strategy and execute with confidence.

Speak with our early phase team to discuss timelines, study design, site strategy, and how to build a faster path to proof-of-concept.