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CNS Trial
Design Services
TRIAL DESIGN
OPTIMIZED FOR CNS SUCCESS
Every successful study begins with a solid design. At CRC, we deliver trial design for Central Nervous System (CNS) clinical research that drives clarity, efficiency, and measurable outcomes. From concept to implementation, our experts ensure each study is structured to meet regulatory expectations, minimize risk, and capture meaningful results.
Our dedication to urgency, consistency, and accuracy ensures your trial starts strong and progresses with confidence. Whether you’re advancing an early-phase proof-of-concept or a late-stage pivotal program, CRC provides the insight and structure to bring scientific innovation to life.
A STRATEGIC PARTNER
IN CNS TRIAL DESIGN
CRC is more than a service provider—we are a strategic CNS CRO partner invested in your success. With deep expertise in consulting, protocol development, and project planning, our team helps sponsors navigate the unique challenges of neuroscience drug development.
Our scientific and operational leaders collaborate early in the process to ensure feasibility, accelerate approvals, and optimize data collection methods. This partnership approach empowers sponsors with designs that are practical, scientifically sound, and submission-ready.
OUR TRIAL DESIGN SERVICES
01.
Patient Population & Inclusion Criteria
Selecting the right population is critical in CNS studies. CRC’s clinical experts help define inclusion and exclusion criteria that align with your trial’s objectives, protect participant safety, and ensure data relevance. We analyze epidemiology, symptom variability, and comorbidity factors to enhance recruitment feasibility and endpoint validity.
02.
Endpoint & Scale Optimization
Accurate endpoint and scale selection determines the strength of your data. CRC partners with sponsors, often including industry KOLs, to identify validated scales and performance measures that reflect meaningful patient outcomes and regulatory expectations. We bring expertise across instruments such as ADAS-Cog, MoCA, HAM-D, and NRS, ensuring each is implemented with precision and reliability.
03.
Protocol Development & Design Consulting
Our medical and scientific leaders have guided dozens of CNS protocols from IND through NDA. We develop protocols optimized for scientific rigor and operational feasibility, integrating adaptive design strategies, placebo-control methodologies, and patient-centric scheduling to minimize burden and maximize signal detection.
04.
Risk Assessment & Feasibility Analysis
CRC applies proactive risk-based design principles to identify potential barriers before they impact timelines or data quality. Through feasibility assessments, site landscape reviews, and patient enrollment modeling, we help sponsors anticipate challenges early—reducing costly mid-study adjustments.
05.
Regulatory & Statistical Alignment
Our biostatistics and regulatory teams collaborate throughout the design process to ensure your trial’s endpoints, randomization, and analysis plans align with FDA and EMA expectations. Early integration of these disciplines ensures consistency from design through data lock, streamlining submission readiness.
BUILDING A
FOUNDATION FOR
RELIABLE RESULTS
A well-designed CNS trial sets the tone for success. CRC’s integrated approach—linking Trial Design, Rater Training and Management, Data Management, Biostatistics, and Quality Assurance—ensures that every protocol is executable, compliant, and backed by data integrity.
Our Customers Benefit From:
- Operational Feasibility: realistic timelines and recruitment targets
- Scientific Precision: validated endpoints and adaptive strategies
- Regulatory Readiness: design decisions that anticipate agency expectations
Together, we create study designs that not only meet regulatory requirements but also deliver data that informs meaningful therapeutic decisions.
get in touch
Ready to partner with the CNS CRO that designs smarter, faster, and more reliable trials?
Contact CRC to discuss how our trial design expertise can optimize your next neuroscience program.