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Bioequivalence Studies

  • The Clinical phase is conducted at our two affiliated clinical sites: University Hospital of Larissa (44 beds) & Arogi (100 beds)
  • The Bioanalytical phase is conducted at affiliated Laboratories, accredited & validated, with extensive experience in bioanalysis & state-of-the-art instrumentation & technology

Study design & protocol development

Clinical phase

  • Subject recruitment
  • Blood sampling
  • Sample handling
  • AE reporting

Bioanalysis

  • Analytical method development & determination of active compounds in biological fluids
  • Bioanalytical method validation assay methods

Pharmacokinetics

  • Determination of pharmacokinetic parameters
  • Pharmacokinetic modeling & simulation

Biometrics

  • Data management
  • Statistical programming & analysis

Integrated clinical study report

  • Clinical, bioanalytical, pk, biometrics reporting

Submission to regulatory authorities, follow-up of the approval procedures & expert opinion

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