Biostatistics & Programming

Services

• Study Design and Protocol Development
• Clinical Development Plans
• Endpoint Selection and Validation
• Sample Size Considerations
• Analysis Plans
• Statistical Reports
• NDA Statistical Sections
• Meta-Analysis
• Statistical Programming
• Custom Tables, Listings and Figures
• Extensive Validation
• Legacy Database Integration
• Submission datasets based on current CDISC guidelines
• Comprehensive database and SAS program documentation