The Clinical phase is conducted at our clinical site with capability up to 60 beds
The Bioanalytical phase is conducted at our accredited laboratory (GMP and GLP certified) with extensive experience in bioanalysis & state-of-the-art instrumentation & technology
Study set up
Study design according to EMA, FDA & ICH guidelines, literature and assessment reports
Protocol, CRF & ICF development
Dossier compilation and submission to Authorities for study approval
Clinical phase
Subject recruitment
Blood sampling
Sample handling
Monitoring
Bioanalysis
Analytical method development & determination of active compounds in biological fluids