Clinical studies

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Clinical studies

“Need for efficacy and safety of the product”

Bioequivalence trials (human or veterinary)

OUR SERVICES

  • 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

OUR SERVICES

  • 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 regulatory requirements for studies
    • Selecting optimal study designs, including:
    • Number of subjects
    • Comparators
    • Efficacy/safety variables
    • Monitoring requirements
    • Statistical considerations
    • Alignment with pharmacovigilance legislation
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER