Close

Biostatistics


Centreum has vast experience in the evaluation of clinical data. Our expertise includes the design and conduct of clinical experiments, the method and way in which data is collected, the analysis of data, and the interpretation of results. Our expertise in regulatory submissions and knowledge of biostatistics helps you to navigate the complexities of study design, randomization, sample size calculation and data visualization etc.


Protocol / Statistical Analysis Plan (SAP)
  • Study design
  • Sample size calculation and power determination
  • Randomization and blinding scheme
  • Statistical methodology according to the study design and type of variables
  • Describe primary and secondary endpoints
  • Evaluate safety/efficacy parameters


Statistical Analysis & Programming
  • Statistical Programming and Review
  • SAS Programming – SDTM/ADaM Datasets and Tables, Listings, Figures
  • Interim statistical analysis for adaptive designs and DSMBs (Data and Safety Monitoring Boards)
  • Data analysis for preparing integrated study reports
  • Integrated Safety and Efficacy Analysis
  • Exploratory analysis for publications, abstracts, and marketing
  •  Analysis of non-clinical trial data from epidemiologic studies and pre-clinical studies


Statistical Reporting
  • Statistical reports following the SAP
  • Statistical sections of Clinical Study Reports (CSR)
  • Statistical sections of integrated study reports
  • TLF creation, In-text table and appendix
  • Patient profiles and ad-hoc reports
  •  Conclusion reports written with input from clients


Other Specialized Services
  • Statistical Modelling
  • PK/PD Modelling
  • Clinical trial planning and design
  • Medical writing
  • Statistical training
  • Biostatistical consulting
  • Participation in Data Safety Monitoring Boards and Adjudication Committees
  • Regulatory submission support