Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)

Statistical Analysis Plan (SAP)

  • SAPs specify the details of the planned statistical analysis, elaborating on the principal features of the technical analysis described in the protocol. They may be included within the clinical study protocol, or provided as a separate, associated document.
  • SAPs document trial objectives, data sources, populations studied, study endpoints, statistical methodology, sensitivity analyses and handling of missing data, as well as the rationale for why these are appropriate.
  • Trilogy can advise on your documentation needs and offers the scientific expertise and industry experience required to provide the full range of documentation required for your clinical trial.