Medical Consultancy

Clinical studies

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Clinical studies

“Need for efficacy and safety of the product”

Bioequivalence trials (human or veterinary)

WE OFFER YOU

  • Design of BE trials (protocol preparation…)
  • Monitoring of BE trials (on-site monitoring of BE studies execution, QA/QC)
  • Statistical analysis of BE trials (noncompartmental pharmacokinetic analysis and statistical evaluation)
  • Preparation of final report
  • Consulting on any of the stages of BE trials:
    • Determining the required studies (fasting, fed, steady-state…)
    • Optimizing design to minimize variability, e.g.:
    • Blood sampling times
    • replicate/semi-replicate/cross over designs
    • Number and selection of subjects
    • Monitoring requirements
    • Statistical considerations
    • Alignment with pharmacovigilance legislation
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Clinical trials

WE OFFER YOU

  • Design of clinical trials (preparation of the study protocol including calculation of required subjects, study design…)
  • Monitoring of clinical trials (on-site monitoring of studies execution, QA/QC)
  • Statistical analysis of clinical trials
  • Preparation of final report
  • Consulting on any of the stages of clinical trials (design, conduct and analysis):
    • Determining regulatory requirements for studies
    • Selecting optimal study designs, including:
    • Number of subjects
    • Comparators
    • Efficacy/safety variables
    • Monitoring requirements
    • Statistical considerations
    • Alignment with pharmacovigilance legislation