Biostatistics

The Biostatistics unit consists of a team of experienced biostatisticians and SAS programmers managing all the statistical activities related to clinical trials.

Our validated software and computer systems are approved by regulatory authorities and are compliant with the appropriate ICH guidelines, particularly E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports), thereby enabling safe and accurate analyses. All analyses are performed using the latest applicable versions of SAS® programs.

Our services include:

  • Full service or independent biostatistical and programming support
  • Support for preliminary meetings with regulatory authorities
  • Protocol and statistical analysis plan development
  • Sample size / Power Calculations
  • Interim analyses and co-ordination of Data Safety Monitoring Boards
  • Preparation of integrated summaries of safety and efficacy for regulatory submissions to the FDA and EMA
  • Randomization services (IVRS/IWRS)
  • Preparation and review of essential study documents (CSP, CIP, SAP, CSR, CIR*)
  • Preparation (programming) of tables, listings and/or graphs
  • Input to publications and assistance in answering editor comments
  • Mapping of old studies to CDISC** format (SDTM, ADaM***)
     

*Clinical Study Protocol, Clinical Investigation Plan, Statistical Analysis Plan, Clinical Study Report, Clinical Investigation Report

** Clinical Data Interchange Standards Consortium

*** Study Data Tabulation Model, Analysis Data Model