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Clinical Studies

Our expert team conducts rigorous clinical studies, ensuring the highest standards of quality and compliance. We provide comprehensive support to bring your pharmaceutical solutions to market efficiently and effectively.

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Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202

1000 Ljubljana

Slovenia

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Bioequivalence trials (human or veterinary):
  • 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 a final report
  • Consulting on any of the stages of BE trials:
    • Determining the required studies (fasting, fed, steady-state…)
    • Optimising 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
Clinical trials:
  • 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 a final report
  • Consulting on any of the stages of clinical trials (design, conduct and analysis)
  • Determining the required studies (fasting, fed, steady-state …)

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With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.

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Billev farmacija vzhod, d. o. o.

Billev Pharma East Ltd.


Tržaška cesta 202


1000 Ljubljana


Slovenia

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