Biostatistics

Biostatistics: The Foundation of Clinical Research Excellence

Biostatistics is the application of statistical methods to biological and medical research. In clinical trials, biostatisticians design studies, analyze data, and interpret results to determine if treatments are safe and effective. Our biostatistics team provides comprehensive support throughout your clinical development process, ensuring methodological rigor and regulatory compliance while translating complex data into actionable insights that advance your therapeutic programs.

Statistical Analysis Plan (SAP) Development

Our team creates comprehensive SAPs that define all statistical procedures for your clinical trials. We establish analysis populations, handling of missing data, statistical methods, and presentation formats. Our SAPs ensure regulatory compliance and alignment with study objectives while documenting procedures before unblinding to maintain data integrity.

Sample Size Calculations and Power Analysis

We determine optimal sample sizes to detect clinically meaningful treatment effects while balancing statistical power and resource constraints. Our statisticians use simulation techniques and advanced statistical software to account for potential dropouts, missing data, and interim analyses to ensure adequate statistical power.

Randomization Schemes

We design and implement randomization strategies (simple, block, stratified) to eliminate bias and ensure balanced treatment groups. Our custom schemes can accommodate various study designs including adaptive trials and incorporate stratification factors for subgroup balance.

Statistical Programming

Our programmers expertly use SAS, R, Python, and other languages to implement statistical analyses, generate CDISC-compliant datasets (SDTM, ADaM), and create tables, listings, and figures. We validate all programming through independent double programming to ensure accuracy and reproducibility.

Clinical Study Reports and Integrated Summaries

We prepare statistical components for CSRs, including methodology descriptions, results interpretation, and comprehensive appendices. For regulatory submissions, we develop integrated summaries of efficacy (ISE) and safety (ISS) that synthesize data across multiple studies to strengthen your evidence package.

Data Monitoring Committee Support

Our statisticians provide independent DMC support including design of interim analyses, alpha spending functions, and stopping rules. We prepare unblinded reports for DMCs while maintaining trial integrity and advise on potential trial modifications based on emerging data.

Statistical Consulting for Regulatory Submissions

We offer strategic guidance throughout the regulatory process, from pre-submission meetings to responding to regulatory questions. Our experts understand global regulatory requirements and help craft scientifically sound arguments to support your product approval.