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Biostatistics

Our statistical team who are well trained in GCP and technical skills of epidemiologic and life sciences statistics .
We use the right modelisation for each kind of study depending on the endpoints settled by the study rational .
We support our client during every step of the development process to make sure the added value of analysis and data of every study are the most efficient and robust.
Our Statistical team can provide:

  • Protocol Development

  • Meta-analysis review of the literature and report

  • Sample size determination

  • Statistical Analysis Plan (SAP)

  • Interim and final biometric analysis

  • Tables, figures and listing

  • Statistical Review of Clinical Study Reports( CSR) in accordance to GCP ICH E3 & E9

Our team have acquired significant statistical expertise and master the application domains of the following methods :

  • Descriptive statistics: description of variables, description of relationships between variables, correlations, Chi² tests…

  • Parametric and non-parametric tests ( Cochran–Mantel–Haenszel tests , Log Rank , Kruskal & Wallis ; Wilcoxon ..)

  • Equivalence and non-inferiority tests

  • Analysis of variance (ANOVA, MANOVA…)

  • Multivariate analysis (linear model, logistic model…)

  • Survival Analysis (Cox model, Kaplan Meier, ...)

  • Meta-analysis using R .