Clinical Sample Analysis is the quantitation of target analyte and its metabolites in a biological matrix for the determination of PK/PD. Clinical sample analysis often includes multiple phases. KCAS supports analysis of samples Phase I – IV studies. Examples of these studies include single ascending dose (SAD), multiple ascending dose (MAD), bioavailability/bioequivalence, drug-drug interactions (DDI), and QT c Prolongation investigations.
Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval of over 300 drugs over our 40 years of operation. KCAS supports normal healthy individuals, disease state subjects as well as pediatric trials. KCAS utilizes tandem technology, LC-MS/MS.
One distinctive service for which our clients choose us is being able to provide clinical kit supplies, formal sample collection protocols, and consulting services. These capabilities have allowed us to support global, multi-center clinical trials for oncology, pediatrics, women’s health and orphan disease trials, each with specialized collection requirements.