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
