DRUG DEVELOPMENT ANALYTICS

BSSI has supported many clients throughout all phases of drug development across almost all therapeutics areas. Even for pre-clinical studies, seeking statistical support early helps ensure that the study objectives are met and resources are not wasted. In the clinical setting, we can support clients from protocol development and study design all the way through to clinical study reports.

  • Pre-clinical study support
  • Protocol and study design review, including sample size determination and randomization
  • Statistical analysis plans
  • PK/PD analysis
  • Production of statistical reports/clinical study reports
  • Generation of CDISC compliant SDTM and ADaM datasets
  • Analysis and interpretation of biomarker information