Avance Clinical CNS Center of Excellence
Avance Clinical has launched a dedicated Center of Excellence for Central Nervous System (CNS) disorders, designed to help biotechs overcome the unique challenges of developing neurological therapies.
With more than 50 CNS trials completed in the past five years, our center builds on proven expertise to deliver integrated, end-to-end clinical trial solutions — from first-in-human studies through pivotal Phase III programs.
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CLINICAL TRIAL EXPERTS
Three decades of experience in biotech drug development
Expert Clinical Trial Services in Neuroscience
We partner with biotechs to address the most pressing challenges in CNS drug development, including:
- Complex protocol design and execution
- Difficult patient recruitment and retention
- High screen failure rates (57% in CNS vs. 36.3% in other therapeutic areas)
Comprehensive
CNS-Focused Services
Protocol Design
Tailored to the complexities of neurological indications
Regulatory Strategy
Expertise across multiple global jurisdictions
Site Networks
Access to CNS-specialized clinical sites worldwide
Patient Recruitment
Targeted strategies to overcome enrollment challenges
Data Management & Analytics
Advanced approaches for complex CNS endpoints
Distinguished Leadership
The CNS Center of Excellence team at Avance Clinical merges a powerful blend of complementary expertise, spanning medical leadership, CRO operations, regulatory strategy, neurobiology, site activation, and preclinical toxicology. Each member brings deep specialization that, together, covers every critical aspect required for successful CNS clinical research. This core team is seamlessly integrated with Avance’s broader service and technical experts in biostatistics, clinical project management, monitoring, data management, and pharmacovigilance. By working collaboratively, they deliver an end-to-end specialist solution, ensuring clients benefit from robust scientific insight, operational excellence, and comprehensive support across all phases of CNS drug development. This unified approach empowers sponsors to confidently navigate the complexities of CNS research, achieving program milestones efficiently and with the highest standards of quality.
Our CNS Center of Excellence at Avance Clinical is proud to bring together a diverse and highly experienced team of experts, each bringing valuable insights and decades of industry experience to every project.
Dr Francesco Bibbiani – Medical Lead
Renowned for clinical leadership in CNS trials, Francesco brings extensive hands-on experience guiding global neuroscience programs. His deep medical expertise ensures the highest standards for patient safety, protocol integrity, and scientific excellence.
Marty Kraut, PhD, PMP – CNS Program Operations Specialist
With years of hands-on leadership in Clinical Research Organization (CRO) CNS operational programs, Marty specializes in driving operational success for trial sponsors. He has managed large-scale and complex CNS clinical programs, ensuring timelines and operational excellence for global studies.
Jorgen Mould, PhD – Regulatory and Scientific Affairs
Dr. Mould’s PhD in neurobiology and impressive record in CNS research deliver deep scientific and regulatory expertise. From global regulatory strategy to scientific protocol design and review, Jorgen ensures that every CNS project meets the most rigorous regulatory standards and leverages the latest neurobiology insights.
Anne Rotten – Site Solution Strategy Expert
Former clinical CNS researcher and now a recognized leader in site strategy at Avance, Annie translates hands-on trial experience into optimal site selection and activation approaches. She excels in connecting trial sponsors with the most suitable research sites and designing strategies for successful CNS program delivery.
Kevin Leach, PhD – CNS Toxicology and Preclinical Programs
Dr. Leach specializes in CNS toxicology and preclinical research, offering expert guidance for early-phase drug development. His experience bridges the gap between discovery, IND-enabling toxicology, and regulatory strategy, helping sponsors confidently progress CNS assets toward clinical development.
Why Our Team Makes a Difference
- Collective expertise covering all facets of CNS clinical trial development – from early-stage preclinical through to late-phase operations.
- Proven track record in delivering successful global CNS trials, even in the most challenging patient populations and regulatory landscapes.
- A multidisciplinary partnership that provides comprehensive solutions for sponsors, accelerating timelines and mitigating risks at every stage.
Let our team guide you through the complexities of CNS drug development, ensuring your program benefits from world-class scientific, operational, and strategic insight.
A Strategic Partnership Model for Biotechs
Built exclusively to serve biotech sponsors, the CNS Center of Excellence offers a true partnership approach, incorporating Australia’s unmatched regulatory advantages:
- Accelerated startup timelines
- Streamlined regulatory pathways
- 43.5% R&D tax incentive
- Global trial structuring expertise
Whether conducting early-phase studies in Australia or managing multi-regional global trials, our model transforms Australia’s benefits into lasting competitive advantages.
Why Choose Avance Clinical
Our key differentiators include:
- Exclusive focus on biotechs across all trial phases
- Expert guidance from specialized Centers of Excellence
- In-house regulatory affairs expertise
- Access to a global network of 2,000+ specialized clinical sites
- Proprietary GlobalReady program for seamless transition from early-phase to late-phase programs worldwide
About Avance Clinical
Avance Clinical is the largest premium, full-service CRO headquartered in Australia, delivering high-quality clinical trials for international biotechs across Australia, New Zealand, Asia, North America, and Europe.
With over 30 years of experience and expertise spanning 250+ therapeutic indications, we provide:
- Preclinical to late-phase clinical trial services.
- Best-in-class regulatory, scientific, and operational expertise
- Recognized leadership with multiple Frost & Sullivan CRO Market Leadership and Customer Value Leadership Awards
Partner with us to accelerate neuroscience drug development.
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