• Protocol development and review
• Statistical Analysis Plan development and review
• Sample size estimation
• Supervision of data management and/or statistical contract research organizations
• Report development and review
• Development and review of integrated summaries
• Support (preparation and attendance) for regulatory meetings (End-of-Phase 2, pre-NDA, advisory committee, protocol assessment)
• Statistical study simulation
• Exploratory analysis
• Due diligence assessment of special protocols and study results
• Participation on Independent Data Monitoring Committee
• Courses on statistics, CSR review, and protocol development

WebbWrites can provide a full range of statistical services including the following: