A Wealth of Experience
BIOSTATISTICS AND SAS PROGRAMMING
Biostatistics
• Trial design (including Group Sequential Design or Adaptive Design)
• Sample size estimation (including sample size re-estimation)
• Development of statistical analysis plan and report
• Development of integrated summary of efficacy and safety (ISE/ISS)
• Interim analysis and Data Monitoring Committee (DMC) support
• Statistical “helpdesk” for immediate consulting needs
• Publication support and market research
• Provide support and interaction with regulatory agencies
• Perform independent Quality Control (QC) analyses
• Provide patient registry support
• Provide post-marketing publication support
SAS Programming
• Generate Tables, Figures, and Listings (TFLs)
• CDISC services: mapping specifications, SDTM/ADaM and define.pdf or defined.xml
• Generate customized patient profiles
• Programming support for Data Management
• Programming for annual safety report
• Generate pooled datasets and TFLs for ISE/ISS