Clinical Bioanalysis of Small Molecules Services

As part of the integrated clinical research platform, Pharmaron’s global LC-MS/MS bioanalytical capabilities in the US, the UK and China provide analytical services to support clinical studies globally. Our tailored analytical solutions meet the needs from early to late-phase clinical trials conducted in a single site or multi-sites. The service includes analysis of drug substances, metabolites and endogenous small molecule biomarkers in various matrices, in compliance with the global regulatory requirements, as governed by SOPs. Our team provides analysis of drug substances, metabolites and small molecule biomarkers in various matrices to support clinical studies from phases I-IV, in support of clinical development and regulatory submission.

• Method development and optimization of transferred methods for the bioanalysis of small molecule-based samples for projects at clinical development stage
• Fully GLP/GCLP compliant method validation per applicable guidelines by global regulatory agencies
• Cross-validation of bioanalytical methods developed and validated among bioanalytical laboratories in the US, the UK and China in support of global clinical trials
• “Fit-for-purpose” or fully validated assay and sample analysis in support of biomarker assessment
• Watson-LIMS® data management and sample tracking
• Quantitative pharmacology support for clinical studies, including PopPK, PBPK, PK-PD and E-R modeling and simulation for dosage and administration prediction, and safety and efficacy analysis