F1 › Training in basic principles in biostatistics and clinical trial methodology

F1 › Biostatistics and clinical trial methodology - Critical reading of articles Understand the best practices and methods of biostatistics applied to randomized clinical trials.

One-day training for an audience that seek to gain insight into an overview of the process and methods for analyzing a clinical trial (ARCs, project managers, regulatory...).
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Acknowledge a comprehensive but accurate understanding of the clinical trial’s methodology

Know the key issues and possible solutions during statistical analysis

Know how to evaluate quickly the methodological quality of a published article concerning the results of a clinical trial


Profile of trainees

Health professionals: physicians, ARCS, pharmacists, researchers, medical representatives. Two-year diploma - The syllabus can be adapted to the needs of biostatistician




1 day / 7 hours


Inter 600 € HT per trainee - at least 3 trainees
Intra Contact us for a service that works best for your business


Inter In Lyon or Paris
Intra On site


Overview : Data-Management et Biostatistiques

  • • Review of the biometric process (clinical data circuit) and introduction of technical vocabulary, abbreviations etc.
  • • Review of the contents of the major documents CRF, Blind-review report, SAP.
  • • Presentation of the various reference documents (ICHE9, ICHE10, EMA Guidelines)
  • • Review of the action plan of a drug (pre-clinical to the AMM)

Summary on statistical concepts

  • • The statistical approach
  • • Descriptive statistics
  • • Inferential statistics (statistical tests, risks, power, sample size)
  • • Application and condition of use of the main tests and analytical models (t-test, Chi 2, ANOVA, logistic regression, survival analysis)
  • • Best Practices in Statistics

Discussion of key methodological points

  • • Populations (ITT, FAS, PP, Safety ...)
  • • Superiority Test, Non-Inferiority Test
  • • Alpha risk, power of a study (assumptions and calculation of sample size, case study on samples or examples from trainees)

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