Biometrics

BIOMETRICS

Pharmalog Biometrics

Biometrics provides a solid foundation for successfully planning and conducting a clinical study. Both the design and methodology of the study and the statistical and clinical evaluation of the collected data require experience to ensure that the study meets the high quality standards of the authorities for regulatory purposes or publications to therefore leads to success.

Monika Rost
Study preparation Statistical analysis Report Dossier analyses for AMNOG

Study preparation

  • All study phases I-IV
  • " Statistical advice and planning according to international standards (incl. FDA CFR Part 11) and with regard to the indication or your specific research question
  • Sample size calculations
  • Randomisation (compilation of random lists / emergency files)

Statistical analysis

  • Statistical analysis plan (SAP)
  • Use of validated programming systems (SAS, WinNonlin and others)
  • Statistical processing of clinical data (tables, listings)
  • Advice on planning and evaluating non-interventional studies (NIS)

Report

  • Biometrical report
  • Review/Compilation of an integrated final report according to ICH-GCP

Dossier analyses for AMNOG

  • Statistical analysis plan (SAP)
  • Use of validated analysis programmes (SAS and others)
  • Statistical processing of clinical data (tables, listings)
  • Generation of statistical output

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