Biostatistics Services
Strategic statistical support throughout the clinical development lifecycle
Clinovare provides experienced biostatistical expertise to support clinical development programs from protocol design through study execution, interim analyses, and final reporting. Our biostatisticians work closely with sponsors, CROs, clinical operations teams, medical monitors, and data management groups to ensure that study designs, statistical methodologies, and analyses are scientifically sound, operationally feasible, and aligned with regulatory expectations.
Whether supporting an early-phase proof-of-concept study or a later-stage registration program, Clinovare delivers practical, high-quality statistical support tailored to the needs of small to mid-size biotech and pharmaceutical companies.
Services Include
- Statistical Sections for Clinical Protocols
Development of protocol-specific statistical methodology and analysis sections that align study objectives, endpoints, and data analysis strategies with regulatory and scientific expectations.
- Randomization Schemes
Design and documentation of appropriate randomization methodologies, including simple, block, stratified, and adaptive randomization approaches to minimize bias and ensure balanced treatment allocation.
- Sample Size and Power Calculations
Statistical determination of appropriate sample sizes based on study objectives, endpoint assumptions, effect sizes, variability, and desired statistical power to support reliable study conclusions.
- Interim Analysis Planning
Development of interim analysis strategies, including timing, objectives, stopping boundaries, and statistical considerations to support data-driven decision-making while maintaining study integrity.
- Statistical Analysis Plan (SAP) Development
Preparation of detailed Statistical Analysis Plans (SAPs) that define analysis populations, statistical methodologies, endpoint analyses, handling of missing data, protocol deviations, and reporting requirements. SAPs are developed in accordance with protocol objectives, regulatory expectations, and industry best practices.
- DSMB / DMC Support and Charter Development
Development of Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) charters that clearly define committee responsibilities, meeting schedules, review procedures, decision-making processes, and statistical reporting requirements. Clinovare can also support preparation of statistical outputs and presentations for DSMB reviews.
- Interim and Final Statistical Analyses
Support for planned interim analyses and final study analyses, including generation of statistical outputs, interpretation of results, and collaboration with clinical and medical teams to support decision-making and reporting activities.
- Regulatory and Submission Support
Statistical support for clinical study reports (CSRs), regulatory submissions, responses to regulatory agency questions, and preparation of statistical documentation required during health authority interactions.
Sponsor and CRO-Specific Statistical Support
Customized statistical consulting services tailored to unique program requirements, including:
- Study design consultation
- Endpoint selection and optimization
- Adaptive trial design support
- Statistical review of CRO deliverables
- Vendor oversight and quality review
- Data review meeting support
- Statistical input for due diligence activities
- Regulatory inspection readiness support
Best Fit When
- Sponsors require experienced biostatistical support without building an internal team
- Protocols require robust statistical design and methodology
- Studies include interim analyses or DSMB oversight
- Clinical programs need independent statistical expertise and review
- CROs require supplemental statistical resources or specialized expertise
- Organizations seek flexible, project-based statistical support aligned with development milestones
Interested in Biostatistics Services?
If you need statistical support for protocol design, SAP development, interim analyses, or regulatory submissions, contact us to discuss your program and scope.