Our experienced Biostatisticians and Programmers produce high-quality, in-depth, timely analysis and reporting of study results across a broad range of therapeutic areas. Our Biostatisticians and Programmers have extensive knowledge of statistical methodology and experimental design.

Biostatistics Services include:

  • Generation or Review of the Statistical Section in Study Protocol
  • Study Design, including Sample Size Determination and Power Analysis
  • Randomization Code Development
  • Input regarding Efficacy and Safety Endpoints
  • Determination of Most Efficient Methods of Statistical Analysis
  • Determination of Primary and Secondary Outcomes
  • Development of Statistical Analysis Plan (SAP) including Mock Tables, Listings and Figures (TLFs)
  • Statistical Programming and TLFs Validation
  • Analysis Dataset Creation and Programming
  • Generation of Interim Reports, PK Reports as needed
  • Generation of Final Statistical Report
  • Transfer of SAS Datasets
  • Statistical Input & Review of Clinical Study Report (CSR)
  • Statistical Representation for all Regulatory Interactions