Study Design

• Protocol development and review
• Sample size
• Randomization

Statistical Analysis

• Statistical analysis plans
• Phase I – Phase IV Clinical Trials
• Adaptive and Sequential
• Bayesian
• Subgroups and outliers using proprietary software and novel statistical method
• Pre-study epidemiology analysis to determine the cost burden of a particular indication
• Economic, behavioral, and humanistic endpoint analysis from ongoing studies
• Post-marketing analysis for comparative studies and claims
• Models to support submission for reimbursement
• Design and analyze quality-of-life (QOL), including treatment group comparisons
• Prepare findings for regulatory submission, journal publication, and coverage
• Identify public, private, and government audiences for outcomes data