Early Phase Center of Excellence for Biotechs
Accelerating First-in-Human and Proof-of-Concept Milestones
Avance Clinical, the Australia-based global CRO partner for biotechs, has been a leader in Early Phase clinical research for more than 30 years. With operations across Australia, New Zealand, North America, Asia, and Europe, the company delivers biotech sponsors both deep local expertise and global reach.
Expanding on this legacy, Avance Clinical has launched its Early Phase Center of Excellence for Biotechs, designed to deliver scientific rigor, innovative trial design, global regulatory insight, and operational excellence for smarter, more efficient early phase trials with significant cost savings for biotechs worldwide.
The Center of Excellence solves the challenges facing early phase biotechs, including approval delays, slow site startups, and inefficient trial designs that drive up costs and compromise data quality.
GET IN TOUCH WITH OUR
CLINICAL TRIAL EXPERTS
Three decades of experience in biotech drug development
How Does This Support
Early Phase Biotechs?
Design Before Execution
Instead of retrofitting protocols after study initiation, our early-phase specialists co-design study plans with sponsors to anticipate safety, PK/PD, biomarker, and translational requirements upfront.
Regulatory Acceleration
Leveraging Australia’s efficient regulatory environment — with no IND required and 5–6 week startup timelines — our regulatory strategists guide CTN/CTX pathways and streamline ethics and submission processes for faster approvals.
Operational Readiness From Day 1
With deep partnerships across Australia’s leading Phase I units and proven global site networks, our teams minimize startup risks and ensure rapid patient recruitment and first-dose timelines.
Continuity Across Phases
Sponsors no longer need to change providers as their programs evolve. Our integrated model provides consistent oversight, quality, and data standards from early development through regulatory submission.
Investor and Partner Confidence
By combining scientific depth, regulatory clarity, and operational precision, we give sponsors and investors the confidence that early data will drive informed, value-creating decisions. To accelerate their clinical programs.
A Global Network of Early-Phase Expertise
The Center of Excellence brings together therapeutic, regulatory, and operations leaders across Avance Clinical’s global footprint — including Australia, New Zealand, Asia, North America, and Europe. This interconnected network provides biotech sponsors with local insight and global alignment — ensuring study designs that meet both regulatory expectations and real-world patient needs.
What This Means for Biotech Sponsors
- Streamlined pathway from preclinical to Phase I and proof-of-concept
- Faster study startup — 5-6 weeks from final protocol to study approval
- Smarter protocol designs that reduce amendments and delays
- Regulatory support across multiple regions
- Data and operational continuity across all trial phases
- Increased stakeholder and investor confidence
Meet Our Expert Team
Partner with Avance Clinical
With over 30 years of experience, operations spanning Australia, New Zealand, Asia, North America, and Europe, and a reputation for award-winning CRO leadership, Avance Clinical’s Early Phase Center of Excellence for Biotechs delivers a new standard of support for biotech innovation.
From preclinical through regulatory submission, our integrated, global approach ensures your molecule’s early-phase success — setting the foundation for future clinical and commercial milestones.
Contact us to learn how our early-phase expertise can accelerate your path to proof-of-concept.
Find out more
- Access up to 43.5% Australian Government R&D Tax Rebate with the Australian Advantage for Early Phase biotechs
- Discover Avance Clinical’s ClinicReady program for pre-clinical biotechs