Biostatistics

This unit consists of a team of experienced biostatisticians managing all the statistical issues 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.

The Biostatistics Unit can provide the following services:

• Study protocol review
• Study protocol writing and design
• Contact with regulatory authorities
• Randomisation
• Writing statistical analysis plan
• Performing interim and final analyses
• Statistical report writing