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Statistical Analysis Plan for Clinical Trials

What is a Statistical Analysis Plan in Clinical Trials?

A Statistical Analysis Plan (SAP) is a document that specifies what clinical trial data will be analyzed and how these analyses will be performed. The SAP describes the extent of the planned analyses, the patient populations to be assessed, and the statistical methods to be used. The SAP must be created before statistical evaluations are conducted and should be reviewed by biostatisticians, statistical programmers, and leading clinical investigators.

Sofpromed’s Statistical Services

Sofpromed is a biometrics CRO specialized in providing biostatistics and statistical programming services, including the development of statistical analysis plans. Our statistical capabilities include:

  • Sample size calculation
  • Statistical analysis plans (SAPs)
  • SAS statistical programming
  • Creation of statistical reports
  • Creation of pharmacokinetics (PKs) reports

Sofpromed’s statistical services are conceived to meet the needs of biotechnology and pharmaceutical companies developing drugs and medical devices in oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious, and respiratory diseases, among others.