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