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Sample Size Calculation for Clinical Trials

What is Sample Size Calculation in Clinical Trials?

Sample size calculation is the estimation of the number of patients required to identify a relevant treatment in a clinical trial. The sample size of a clinical study can be calculated by using many different methods and formulas, which requires the specialized knowledge of an experienced biostatistician. Sample size calculation is a fundamental aspect of clinical trial design since it has a direct impact on the robustness of the answer to the main clinical research question.

Sofpromed’s Biostatistics and Statistical Programming Services

Sofpromed is a clinical research organization (CRO) specialized in providing biostatistics and statistical programming services, including sample size calculations. Our statistical capabilities include:

  • Sample size calculation
  • Statistical analysis plans (SAPs)
  • SAS programming
  • Statistical reports
  • Pharmacokinetics (PKs) reports

Sofpromed’s statistical services are offered for phase I-IV clinical trials and post-approval studies in a wide variety of therapeutic areas such as oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious, and respiratory diseases, among others.