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