Biostatistics

Our experienced biostatisticians provide trial design consultation, statistical methodology recommendations, programming expertise, and interpretation of data necessary to deliver your trial results efficiently and on time. We provide consistent program and project teams, all of which include senior-level statistical oversight. Data analysis is performed using industry-standard SAS® software. All programming follows thorough quality control procedures including validation by an independent programmer. Our biostatistics services include:

  • Protocol review and study design
  • Generation of randomization schedules
  • Comprehensive data analysis plans, including sample size determinations, detailed descriptions of statistical methodologies, and mock examples of deliverables.
  • Development of customized analysis programs thoroughly tested and validated according to documented procedures
  • CDISC programming, including conversion of legacy data
  • Interpretation of study results and writing support for the preparation of study reports
  • Integrated efficacy and safety analysis for regulatory submissions
  • Statistical and programming support for DMCs
  • Attendance at regulatory agency meetings