Join our Newsletter
From medical white papers to invite only networking, join our newsletter to stay connected with the world of CRC.
CNS Biostatistics & Statistical Programming Services
Transforming Data into Insights
At CRC, our Biostatistics and Statistical Programming teams provide the trial design and analytical expertise necessary to assess efficacy, safety, and overall trial success with precision and confidence. With decades of experience in Central Nervous System (CNS) clinical research, we collaborate seamlessly with sponsors from the study design stage through randomization, advise on detailed statistical analysis plans and endpoint assessments to ensure alignment throughout the study lifecycle, and transform trial data into actionable insights.
Our biostatisticians and programmers work hand in hand with Data Management, Rater Services, and Clinical Operations to ensure statistical integrity across every stage of the study. From early translation into the clinic through pivotal programs, the CRC team delivers analyses that are scientifically sound, regulatory-ready, and tailored to the nuances of neuroscience research.
Statistical Rigor that Powers CNS Drug Development
CNS studies are inherently complex, often requiring long durations, subjective endpoints, and mitigation strategies to reduce variability in patient responses. CRC’s Biostatistics and Statistical Programming teams understand these challenges and design robust statistical approaches that enhance sensitivity, reduce bias, and optimize study outcomes.
Whether you’re measuring subtle cognitive change, behavioral outcomes, or functional endpoints, CRC ensures every analysis aligns with your scientific and regulatory objectives – so you can move forward with confidence.
Integrated Statistical Support for Reliable Results
At CRC, Biostatistics is more than just analysis – it’s the backbone of reliable research. Our team of statisticians integrate closely with our Data Management and Quality Assurance teams to ensure all data are validated, traceable, and audit-ready. This holistic approach guarantees that every analysis reflects accuracy, consistency, and scientific integrity.
Our collaboration with clinical and scientific teams allows sponsors to anticipate challenges, interpret findings confidently, and effectively navigate regulatory expectations for CNS clinical development.
Our Biostatistics & Statistical
Programming Services
01.
Trial Design & Statistical Power
Our biostatistics team collaborates early in the planning and design process to ensure trials are powered to meet study objectives for the intended audience, with the right level of certainty, whether they be fixed or adaptive designs, from early phase through to pivotal efficacy studies.
02.
Randomization
CRC partners on randomization strategies that minimize bias and support balanced, reliable results. Whether fully integrated with an IRT system for central randomization incorporating drug supply management or for a single site with an unblinded pharmacy, our team maintains flexibility to meet the needs of each study in a cost-effective manner.
03.
Statistical Analysis Plan (SAP)
With support from statistical programming, our biostatisticians create detailed Statistical Analysis Plans (SAPs) that define the methodology, endpoints, and analysis frameworks that guide study execution. Each plan is tailored to meet regulatory expectations and align with ICH-E9 (R1) guidelines for CNS trials for the intended audience, at the right stage of development – ensuring reproducibility, transparency, and compliance.
04.
Efficacy & Safety Analysis
Our team conducts rigorous efficacy and safety analyses to evaluate primary and secondary endpoints, adverse event patterns, and treatment effects. We apply advanced statistical techniques to ensure every result meets the highest standards of validation, supporting data-driven decision-making throughout the study lifecycle. Using Pinnacle 21 Enterprise, our team creates the fully compliant FDA CDISC submission ready package.
05.
Estimands & Missing Data Handling
Defined in the SAP, CRC’s specifications for handling missing data, tailored for the objectives of the trial and the stage of development, and consistent with the estimand framework and the ICH E9(R1) addendum in order to ensure targeted inference aligns with internal decision-making needs and regulatory expectations.
06.
Integrated Analyses
Our biostatisticians conduct both formal meta-analyses and integrations of prior and current study data to not only meet regulatory filing requirements, but also to provide broader program-level insights. This strategic support helps optimize trial design, increase the likelihood of achieving key development goals, and provide context for CNS program performance, offering broader insights that inform clinical and commercial strategy.
Why Sponsors Choose
CRC for Biostatistics
Through our analytical rigor and commitment to quality, CRC delivers insights that turn data into progress – and progress into breakthroughs.
Key Benefits:
- Decades of experience supporting CNS clinical research across neurology, psychiatry, and analgesia
- Proven statistical expertise from first-in-human to FDA submission and through to FDA approval
- Hands-on collaboration with cross-functional project teams for full alignment
- Deep familiarity with ICH-E9 (R1) and FDA statistical guidance
- Commitment to actionable, transparent, and reproducible data
get in touch
Ready to Partner with a CNS CRO that Transforms Data into Decisions?
Contact CRC to learn how our biostatistics expertise can strengthen your next neuroscience trial.