Delivering Flexibility in a Multi-site Global Harmonized Clinical Trial

The project required Eurofins Bioanalytical Services to perform cross-validation of a Pharmacokinetic (PK) assay and three Pharmacodynamic (PD) biomarker assays. This required supporting sample analysis for sites in the United States within a global clinical trial. The samples analyzed are from pediatric patients with a rare, complex, and life-threatening inflammatory syndrome. The client’s drug (where there is currently no treatment) is a monoclonal antibody biotherapeutic designed to bind and neutralize an inflammatory cytokine, which drives the pathogenesis of the disease.

PK and PD biomarker data are required in near real-time to understand the disease evolution during treatment.