Česky EnglishRussian
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Clinical Trials and Bioanalyses

 

II.-IV. Phase Clinical Trials

We can offer the following organization of trials as required by the sponsor. For example:

  • 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
  • Packaging and/or blinding of Investigation Products according to Good Manufacturing Practice (GMP) requirements
  • Investigator and medical sites proposal
  • Study monitoring
  • Processing and statistical evaluation of data
  • Clinical report writing
  • QA/QC
  • Archiving of data and documents