The Clinical phase is conducted at our affiliated clinical sites
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
