CRO benchmarking for clinical biomarker analysis outsourcing

References

• 1. Bennett P , Beyerlein DF , Hucker R et al. Outsourcing in bioanalytical laboratory. Bioanalysis 5(20), 2253–2462 (2013).
  Google Scholar
• 2. Tsou JA . Managing biomarker outsourcing: CRO evaluation, streamline outsource process, and quality management. In: Translating Molecular Biomarkers into Clinical Assays. Weiner R Kelley M (Eds). Springer, NY, USA (2016).
  Google Scholar
• 3. Hayes R . Bioanalytical outsocuring: transitiong from pharma to CRO. Bioanalysis 9(15), 1149–1152 (2017).
  CASGoogle Scholar
• 4. Woolf E , Chaudhary A , Breiding S . Current status of bioanalytical outsourcing: a pharma perspective. Bioanalysis 9(15), 1165–1169 (2017).
  Google Scholar
• 5. Wang T , Gusev AI . Ensuring quality and compliance in outsourcing of bioanalysis of clinical biomarkers. Bioanalysis 9(7), 501–504 (2017).
  CASGoogle Scholar
• 6. Zimmer D . Bioanalytical outsourcing models in pharmaceutical companies. Bioanalysis 9(15), 1145–1148 (2017).
  CASGoogle Scholar
• 7. Stovold C , Milligan F , Hawthorne G , Pattison C , Wilson A . Changing shape: evolving an outsourced bioanalytical strategy to support the changing needs of drug development. Bioanalysis 9(15), 1135–1137 (2017).
  CASGoogle Scholar
• 8. Abberley L . Outsourcing of bioanalysis at GSK: a hybrid approach with a robust support model. Bioanalysis 9(15), 1139–1144 (2017).
  CASGoogle Scholar
• 9. Yee LM , Lively TG , McShane LM . Biomarkers in early-phase trials: fundamental issues. Bioanalysis 10(12), 933–944 (2018).
  CASGoogle Scholar
• 10. Allinson JL . Clinical biomarker validation. Bioanalysis 10(12), 957–968 (2018).
  CASGoogle Scholar
• 11. Bioanalytical Method Validation Guidance for Industry. US Department of Health and Human Services, US FDA, Rockville, MD, USA (2018). www.fda.gov/media/70858/download
  Google Scholar
• 12. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). European Parliament and Council of the European Union L119, 1–88 (2016).
  Google Scholar
• 13. Verhaeghe T . Bioanalytical outsourcing strategy at Janssen Research and Development. Bioanalysis 6(10), 1321–1327 (2014).
  CASGoogle Scholar
• 14. Dillen L , Verhaeghe T . Outsourcing bioanalytical service at Janssen Research and Development: the sequel anno 2017. Bioanalysis 9(15), 1195–1201 (2017).
  CASGoogle Scholar
• 15. Arfvidsson C , Severin P , Holmes V et al. AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance: an evolutionary outsourcing model. Bioanalysis 9(15), 1181–1194 (2017).
  CASGoogle Scholar
• 16. Hucker R , James S , Watson C . Interactions between clients and outsourced CRO: mind the gap. Bioanalysis 9(15), 1153–1156 (2017).
  CASGoogle Scholar
• 17. Bennett P . Meeting the challenges of bioanalytical outsourcing: understanding the hidden cost of price pressure. Bioanalysis 3(22), 2491–2493 (2011).
  CASGoogle Scholar