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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Clinical Trials and Bioanalyses

 

Bioequivalence / I.-II.a phase Clinical Trials

QUINTA-ANALYTICA s.r.o has multi-year experience performing pharmacokinetic/bioequivalence studies of different designs . Our team of experienced experts carries out complete studies on healthy volunteers, special populations of healthy volunteers, as well as populations of subjects with special health conditions.

 
  • Clinical part
    • Study Protocol writing and study design
    • Subject size determination and randomization
    • Case Report Forms (CRFs) design
    • Informed Consent Forms writing
    • Independent Ethics Committee submissions
    • Regulatory Authority (State Institute for Drug Control) submissions
    • Recruiting of healthy subjects and special populations
    • Entrance and follow-up examinations including laboratory tests
    • Bioequivalence/Phase I-IIa clinical trials
    • Adverse event reporting
    • Clinical data processing and statistics
  • Bioanalytical part
    • Drug/metabolite assay development and validation
    • Drug/metabolite analysis in biological matrices
  • Data processing, biostatistics and report writing
    • Bioanalytical data processing and pharmacokinetic parameters calculations
    • Biostatistics
    • Clinical, bioanalytical and biostatistic report writing
    • Documentation archiving
  •  QA/QC