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Biostatistics

Comprehensive and extensive experience in the design and analysis of clinical studies. 

Statistical services have always been a relevant component of the FTH's services over the last 20 years. Our team has strong experience in all phases of research and development from pre-clinical analysis to clinical and post-marketing support across a wide range of clinical trial methodology and the treatment of large amounts of data. FTH also provides all levels of support from tailored consultancy for protocol design through to study level analysis of complete listings, figures, tables with the aim to reach conclusions within the statistical scenario.

Biostatistics activities include:

  • Data analysis in Pre-Clinical Studies

  • Design and Elaboration of the Statistical Analysis Plan (SAP) 

  • Randomization

  • PK / PD Analysis

 

  • Drafting of Clinical Study Reports and Statistical Reports

  • Interim Analysis, and Data Safety Monitoring Boards (DSMBS)

  • Technical support for the integration of safety and accurate data prior to regulatory approval (ISS / ISE)