The Avance Clinical Advantage for European Biotech Companies
Accelerate Your Global Drug Development Pathway
Partner with Avance Clinical to fast-track your program from discovery to clinical proof of concept.
Start your early-phase studies in Australia to gain regulatory speed, scientific flexibility, and significant cost efficiencies—then seamlessly expand globally with the same expert team.
At Avance Clinical, we help European biotechs de-risk development and compress timelines by initiating first-in-human and early-phase studies in Australia, then transitioning efficiently into later-phase trials across North America, Asia, and beyond.
Our GlobalReady™ approach integrates:
- Scientific and Regulatory Leadership
- Seamless Operational Continuity Across Regions
- Experience Across a Wide Range of Disease Indications and Product Types
CONTACT OUR GLOBAL IN HOUSE SCIENTIFIC &
REGULATORY AFFAIRS TEAM
Delivering more than 30 years experience of drug development expertise
Extensive Early-Phase Expertise
Across Modalities and Therapeutic Areas
Avance Clinical manages early-phase programs across all major product types, from small molecules and monoclonal antibodies to advanced modalities such as antibody-drug conjugates, cell-based therapies, viral vector products, and nucleotide-based therapeutics.
We collaborate with an extensive network of clinical investigators and key opinion leaders (KOLs) across diverse disease indications. Within Avance, our in-house scientific specialists in Oncology, CNS, Renal, and Cardiometabolic disorders provide deep therapeutic insight that shapes smarter protocol design and development strategy.
Avance Clinical also has unmatched expertise in first-in-human (FIH) studies, having pioneered hybrid healthy volunteer/patient Phase I trial designs in Australia. These innovative approaches maximize data value in early development and set the stage for Phase II designs with a higher probability of success.
Accelerate your pathway to clinical proof of concept, efficiently, globally, and with confidence.
Why European Biotechs
Choose Avance Clinical
Fast Start in Australia – Accelerate, Simplify, and Save
- Speed: Move from final protocol to study approval in as little as 5–6 weeks.
- Simplicity: No IND required for early-phase studies under Australia’s Clinical Trial Notification (CTN) scheme.
- Economics: Receive a 43.5% R&D tax rebate—a major source of non-dilutive funding.
- Global Acceptance: Generate ICH-GCP–compliant data accepted by FDA, EMA, and other global regulatory agencies.
- Early Value Creation: Access high-quality early data to support funding and licensing milestones.
- Outcome: Achieve faster go/no-go decisions and a smoother transition to global trials.
Seamless Global Expansion
- Transition effortlessly from Australian FIH studies to Phase II/III trials in North America, Asia, and beyond.
- Maintain one team, one program, one data standard—ensuring scientific and operational continuity across regions.
Scientific & Regulatory Leadership
- Work directly with senior scientific and regulatory experts guiding study design and global development strategy.
- Proven experience with regulatory frameworks including FDA, TGA, Medsafe, MFDS, and TFDA.
Therapeutic Depth and Breadth
- Experience across a wide range of disease indications, supported by an extensive network of disease area experts and KOLs who contribute scientific and clinical insight throughout development.
- Deep in-house expertise in Oncology, CNS, Renal, and Cardiometabolic disorders, enabling data-driven study designs that align with evolving standards of care and accelerate decision-making.
Therapeutic Breadth Across the Development Continuum
Avance Clinical has supported more than 250 early-phase clinical trials in the past five years, with strengths extending into later-phase studies in Oncology, CNS, Renal, and Cardiometabolic disorders.
Our integrated scientific, clinical and operational expertise ensures continuity from first-in-human through proof of concept and beyond.
ONE PROGRAM. ONE TEAM.
GLOBAL SCALE
From first-in-human through later-phase global studies and all the way to your key inflection milestones, Avance Clinical ensures continuity, speed, and scientific integrity, keeping your development program moving without disruption.
Our Integrated Approach Delivers
- Continuous scientific and operational leadership from early development through proof of concept and beyond
- Comprehensive regulatory submission support for smooth transitions across regions
- Access to a global site network spanning North America and the Asia-Pacific region, including Australia, New Zealand, South Korea, and Taiwan, plus collaboration with trusted partners in Europe
- Unified biometrics, safety, and regulatory standards ensuring data consistency and quality at every phase
With one team guiding your investigational product from early clinical evaluation to global late-phase trials, Avance Clinical provides the expertise, oversight, and scalability needed to accelerate development and maximize value.
Scientific & Regulatory Expertise
That Drives Early Development and Proof of Concept
At Avance Clinical, you work directly with senior experts who bring deep scientific and clinical insight and global regulatory experience to every program. Our team combines strategic foresight with hands-on operational knowledge to streamline early development and accelerate the transition to clinical proof of concept.
Our Expert Services Include:
- Clinical Pharmacology and Early Development Strategy
- Global Regulatory Strategy (FDA, TGA, Medsafe, MFDS, TFDA)
- IND-Enabling Preclinical and Translational Development Planning — integrating toxicology and clinical entry strategy for seamless FIH transition
- Biostatistics and Adaptive Trial Design
- CMC Strategy and Regulatory Support
Discover how our scientific and regulatory expertise helps sponsors design and deliver smarter, faster trials – from early development through proof of concept.
EU Biotech Benefits
Accelerate Development.
Maximize Value.
Partner for Success.
Faster Start and Early Data
Launch first-in-human studies in as little as 5–6 weeks, with early access to data supporting funding, valuation, and licensing milestones.
Capital Efficiency
Leverage Australia’s 43.5% R&D rebate for substantial non-dilutive funding, extending your clinical runway.
Global Regulatory Alignment
Conduct ICH-GCP–compliant studies under the CTN scheme - no IND required - with data recognized by FDA, EMA, and other global agencies.
Seamless Progression to Later Phases
Transition smoothly from early-phase trials in Australia to global Phase II/III programs through Avance’s GlobalReady™ framework and trusted international partners.
Ready to Accelerate?
Start fast. Generate value early.
Build global momentum with Avance Clinical.