Statistical Analysis

Based on a well-developed analysis plan, statistical analysis implementation provides sponsors with timely, high-quality deliverables. ARIANNE biostatisticians are committed to your success starting with a well-thought and carefully designed analysis plan all the way through to the analysis of study data. We ensure complete, concise reporting, production of tables, listings and graphs in compliance with FDA and ICH guidelines.

• Development of comprehensive methods reports that document planned and exploratory analyses
• Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results

Analysis Plans

Concise, accurate reporting of study results begins with development of clear protocols and accurate, user-friendly case report forms. Our statisticians interact with sponsor scientists to develop a comprehensive statistical analysis plan, including:

• Overview of study objectives
• Description of study population
• Sample size rationale and statistical power
• Methodology for summary and analysis of demographic, baseline, efficacy and safety data
• Description of statistical methodology
• Shells of all planned tables, listings and graphs

In addition to providing expert statistical support for individual studies and programs, our statisticians provide consultative statistical support, including:

• Program development advice
• Statistical methodology review
• Analysis interpretation
• Report review
• Presentation to regulatory authorities
• Data Safety Monitoring Board (DSMB) participation
• Preparation of annual regulatory reports