CNS Trials Are Difficult — Do They Have To Be?

Access to CNS Expertise Across
Protocol Development and Execution

The CNS CoE advises sponsors through every stage of clinical development — from early protocol design to regulatory preparation and study execution. Our experts provide guidance on CNS-specific challenges such as complex protocol design, recruitment and retention difficulties, and high screen failure rates. We also deliver therapeutic and protocol-specific training to project teams, enhancing their understanding of CNS indications and improving site monitoring efficiency. In addition, we collaborate with specialized rater training and eCOA vendors to reduce variability in CNS assessments, thereby strengthening data quality and integrity.

Specialized Support for Emerging Biotechs

Smaller and emerging biotech companies often lack the internal resources needed to advance a therapy from preclinical to clinical stages. Avance Clinical’s model is designed to accommodate small-to-mid-sized teams, offering flexible, fit-for-purpose solutions and direct scientific engagement. We assist sponsors in identifying target populations, selecting appropriate endpoints, meeting regulatory expectations, and performing gap analyses to ensure readiness for clinical development. The CNS CoE emphasizes proactive communication, transparent governance, and tailored program design to support clients at key inflection points, including funding initiatives and milestone decisions.

Designing Feasible and Meaningful CNS Protocols

Effective protocol design begins with understanding the current trial landscape for each indication—analyzing prior study designs, successful and failed endpoints, and regulatory feedback. Our team critically evaluates inclusion and exclusion criteria to ensure they are appropriately defined and feasible. We also engage key opinion leaders (KOLs) with deep expertise in specific CNS disorders to refine study design.

Because CNS trials often experience high dropout rates, we guide sponsors in developing patient- and caregiver-friendly protocols that balance comprehensive data collection with practical feasibility. Understanding patients’ and caregivers’ primary needs and treatment expectations ensure that study endpoints align with outcomes that matter most to patients and caregivers.

Enhancing Recruitment and Retention

The CNS CoE strengthens recruitment through partnerships with CNS-specialized global site networks experienced across a range of indications. We leverage targeted recruitment strategies and work with site solution partners to align studies with well-characterized patient populations. To address screen failure and dropout rates, we collaborate with sponsors to optimize inclusion thresholds, refine comorbidity and concomitant medication allowances, and ensure screening procedures identify suitable participants.

Our patient-centric approach emphasizes reducing participant burden and fostering engagement through logistical support, clear communication of expectations, and collaboration with patient advocacy groups.

End-to-End Regulatory Guidance

Avance Clinical offers regulatory expertise spanning preclinical research, clinical development, operations, and submissions. Our team helps align early regulatory strategies with protocol design to facilitate streamlined approvals and global scalability. Sponsors benefit from Australia’s streamlined regulatory pathways and R&D tax incentives, as well as Avance Clinical’s GlobalReady framework, which enables smooth expansion into the U.S. and other international markets.

The CNS CoE also supports go/no-go decision-making by ensuring clinical assessments and biomarker data adequately address key efficacy and biological impact endpoints. This helps sponsors gather meaningful evidence, identify potential risks, and determine the most efficient development path forward.

Steering CNS Trials Toward Success

CNS trials are among the most challenging in clinical research, encumbered by subjective endpoints, complex populations, and high dropout rates. Yet with the right expertise and infrastructure, these challenges can be transformed into opportunities for more insightful, patient-aligned research. With Avance Clinical’s CNS Center of Excellence, sponsors gain the strategic guidance, operational excellence, and scientific rigor needed to bring transformative CNS therapies closer to patients worldwide.