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

The 5th Global CRO Council for Bioanalysis (GCC) meeting, held in Barcelona, Spain, in November 2011, provided a unique opportunity for CRO leaders to openly share opinions, perspectives and to agree on bioanalytical recommendations on incurred sample reproducibility in multi-analyte assays, regulation of quality assurance/bioanalytical consultants and regulatory requirements for GCP. 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...