ABSTRACT
The AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance (CBioA) was launched in 2011 after a period of global economic recession. In this challenging environment, AstraZeneca elected to move to a full and centralized outsourcing model that could optimize the number of people supporting bioanalytical work and reduce the analytical cost. This paper describes the key aspects of CBioA, the innovative operational model implemented, and our ways of ensuring this was much more than simply a cost reduction exercise. As we have recently passed the first 5-year cycle, this paper also summarizes some of the concluding benefits, wins and lessons learned, and how we now plan to extend and develop the relationship even further moving into a new clinical laboratory partnership.
Subject(s)
Clinical Laboratory Services/economics , Drug Industry/economics , Outsourced Services , Clinical Laboratory Services/organization & administration , Clinical Laboratory Services/standards , Communication , Outcome Assessment, Health Care , Reference StandardsABSTRACT
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.
Subject(s)
Biological Assay/standards , Biomarkers/analysis , Calibration , Chromatography, High Pressure Liquid/standards , Contract Services/organization & administration , Humans , Tandem Mass Spectrometry/standards , Validation Studies as TopicSubject(s)
Biomarkers/analysis , Chemistry Techniques, Analytical/standards , Pharmaceutical Preparations/analysis , Calibration , Chemistry Techniques, Analytical/methods , Drug Discovery/education , Europe , Humans , Pharmaceutical Preparations/standards , Quality Control , Reference Standards , Reproducibility of Results , Societies, Scientific , Validation Studies as Topic , WorkforceABSTRACT
The 3rd Global CRO Council Closed Forum was held on the 3rd and 4th July 2011 in Guildford, United Kingdom, in conjunction with the 19th International Reid Bioanalytical Forum. In attendance were 21 senior-level representatives from 19 CROs on behalf of nine European countries and, for many of the attendees, this occasion was the first time that they had participated in a GCC meeting. Therefore, this closed forum was an opportunity to increase awareness of the aim of the GCC and how it works, share information about bioanalytical regulations and audit findings from different agencies, their policies and procedures and also to discuss some topics of interest and aim to develop ideas and provide recommendations for bioanalytical practices at future GCC meetings in Europe.
Subject(s)
Pharmaceutical Preparations/analysis , Technology, Pharmaceutical/organization & administration , Biomarkers/analysis , Chromatography, High Pressure Liquid , Government Regulation , Hemolysis , Humans , Tandem Mass SpectrometryABSTRACT
"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"