Ensuring quality and compliance in outsourcing of bioanalysis of clinical biomarkers

Productivity and efficiency of pharmaceutical R&D has been a subject of multiple discussions and publications. Outsourcing is one of the common approaches pharmaceutical industry employs to address R&D challenges. Outsourcing in the pharma R&D was initially started in 80s as a cost-cutting measure. More recently, outsourcing is employed by large pharmaceutical companies for efficiency gains and allowing internal R&D functions to focus on innovation and core competency. In addition, outsourcing can facilitate the resource–capacity management (e.g., peak resource demands), project flexibility, access to specific instrumentation/technologies or regulatory compliance set up (e.g., CLIA or GLP). Small- to mid-size pharma companies are also following this outsourcing trend. Furthermore, some companies are putting outsourcing at the center of their business model. As a result, clinical outsourcing has significantly grown across late-stage clinical trials and into translational clinical studies. Clinical biomarkers are another growing area of pharmaceutical R&D. It is primarily driven by potential for personalized medicine, faster decision making and accelerating drug development. The aim of this editorial is to provide a holistic picture of clinical biomarker outsourcing, focusing on exploratory and molecular biomarker bioanalysis