BIOSTATISTICS SUPPORT FOR CLINICAL STUDIES

• Trial design and protocol development
• Assist protocol design and write the statistical section
• Sample size estimation (including sample size re-estimation)
• Development of Statistical Analysis Plans (SAPs) including mock tables for individual studies or ISS/ISE (Integrated Summary of Safety/Integrated Summary of Efficacy)
• Interim analysis and Data Monitoring Committee (DMC) support
• Publication support and post-marketing publication support
• Development of Bio research Monitoring (BIMO) Listings