Recommendations on biomarker bioanalytical method validation by GCC

The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation. The GCC was formed in an effort to bring together many senior level CRO representatives to openly discuss bioanalysis and the regulatory challenges, many of them exclusive to the outsourcing industry. CROs are unique in that they work with many different pharmaceutical companies and agencies, which results in a unique and comprehensive perspective on scientific approaches in relation to regulatory requirements. Since...