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Biostatistics

- Clinical Development Plans & Study Design

- Statistical Analysis Plan

- Tables, Figures and Listings

- Statistical Analysis and Reporting

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Biostatistics - Clinical Development Plans & Study Design

Our experienced biostatisticians have extensive expertise in providing statistical input into clinical development plans. With our in-depth knowledge of worldwide regulatory agencies and guidelines, we can ensure that development plans satisfy global statistical regulatory requirements.

Our biostatisticians frequently consult on clinical study design. We’ve successfully designed fixed sample size trials, sequential studies, adaptive design studies, and longitudinal studies. Our design services include:

• Study design
• Sample size estimation
• Selection and definition of study endpoints
• Statistical analysis strategies
• Timing and scope of interim analyses
• Randomization schedules