Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)

The Global CRO Council for Bioanalysis (GCC) was formed in an effort to bring together many senior-level representatives of CROs to openly discuss bioanalysis and the regulatory challenges, many of them unique to the outsourcing industry. CROs are unique in that they work with many different pharmaceutical companies and agencies, which results in a distinctive and comprehensive perspective on scientific approaches in relation to regulatory requirements. More information on GCC unique structure can be found in the publication titled ‘Formation of a Global Contract Research Organization Council for Bioanalysis’ [1] and its scientific activities have been subsequently published in articles and White Papers [2–6].