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Biometrics

A STRENGTHENED MULTIDISCIPLINARY APPROACH TO GIVE MEANING TO YOUR DATA 

ICTA’s Biometrics Department offers, as stand-alone services or as part of ICTA's full-service solution, the following services: 

  • Consulting in methodological design (pre- and post-marketing clinical studies)
  • Data Management (paper CRF, questionnaire, e-CRF, e-PRO)
  • Biostatistics, biomathematics and modelisation
  • Medical writing

Its organization joins the expertise of the medical and scientific affairs department with the IT department which interact throughout the study. 

  • The medical affairs department provides the essential medico-scientific knowledge 
  • The IT department provides, via the i-SIT* collaborative platform, the computer tools and applications (e-CRFs, IWRS) necessary for the study conduct, the data collection, the data management, the data processing and the data analysis.

For international studies, the entire process of data collection, processing and analysis is centralized in ICTA’s headquarters under the responsibility of the project leader who acts, via the matrix system, in close collaboration with the data managers and statisticians.

ICTA’s BIOSTATISTICS department, a reference in clinical R&D

  • Pre-marketing clinical studies
  • Post-marketing clinical studies
  • Pharmacoepidemiologic studies 
  • Pharmacoeconomic studies
  • Quality of life studies
  
  • Study customized IT tools developed incompany (e-CRFs, i-WRS) 
  • Services in compliance with regulatory requisites (ICH, GCP, GCDMP, CDISC, etc)
  • Computerized system validation process 
  • Infrastructure in compliance with 21 CFR Part 11**
 

INFERENCES

  

data analysis
  • Frequentist approaches
  • Bayesian approaches
  • Modelisation
  
  • Traditional 
  • Multivariate analyses 
  • Bayesian networks
  • Data mining
  • Neural analysis