Biostatistics

Biostatistics is one of the crucial elements of clinical research. The accuracy of the calculation of the sample size and selection of the proper statistical methods are vital for valid results and reports. The most appropriate way is to perform statistical planning beforehand (SAP development) and to perform statistical calculations and results interpretation at the end of the study. Data integrity is always higher if a single team does the planning and statistical calculations.

Pharmaxi’s Biostatistics Services:

Development of overall strategy of statistical analysis.
Sample size and power calculations – determining the number of participants needed to achieve reliable results.
Selection of statistical analysis methods and protocol statistical input – ensuring study objectives and endpoints are statistically sound and feasible.
Statistical analysis planning (SAP) – creating a detailed plan outlining how endpoints and safety data will be analyzed.
Interim analysis planning – defining stopping rules, futility analyses, or adaptive design elements.
Statistical programming (CDISC (ADAM and SDTM)-compliant)).
Preparation of statistical outputs (tables, listings, figures).
Efficacy analysis – comparing treatment groups on primary and secondary endpoints (e.g., survival analysis, regression models, repeated measures).
Safety analysis – summarizing adverse events, lab values, and vital signs.
Subgroup analyses – exploring effects across patient subgroups.
Preparation of statistical sections in Clinical Study Reports (CSR) – ensuring compliance with ICH E3 and regulatory standards.
Responses to regulatory queries – justifying analysis choices and results interpretation.

Our main purpose is to offer you the activities that best suit your project needs, while ensuring our proposal is reasonable as well as both cost and time efficient.

Contact us with your questions or concerns. We offer a free half-hour consultation with a clinical trial expert to discuss your request.