QC/Vendor Oversight Program


  • Sponsor utilizing FSP model for global Clinical Monitoring support
  • Vendor clinical monitoring team had high turnover rate > 40%, inexperienced CRAs with minimal therapeutic expertise, and little understanding of the protocol
  • CRA manager lacked leadership skills and used a hands off approach.



turnover rate


  • Sponsor engaged KPS to perform QC Assessment Evaluation of active studies
  • KPS completed 60 monitoring oversight visits in Europe, South America, and North America in five (5) months
  • All QC Monitoring Reports delivered to Sponsor outlining required next steps



monitoring oversight visits in Europe


  • Remediation plans implemented to clean up backlogged studies
  • KPS deployment of Global Monitoring & Oversight Program
  • In Jan 2015, new KPS CRAs hired and existing vendor monitors re-badged and deployed under KPS Management