Clinical Monitoring Oversight Case Study

Opportunity

  • Sponsor utilizing a Vendor with an alternative 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
  • Vendor CRA manager lacked leadership skills and used a hands-off approach.

Solution

  • Sponsor engaged KPS to perform CRA 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

Oversight visits in Europe, South America, and North America in five (5) months

Results

  • Remediation plans implemented to clean up backlogged studies
  • KPS deployment of Global Monitoring CRA Team with Sponsor Oversight
  • KPS CRAs hired and deployed under KPS Management for Sponsor’s global Clinical Monitoring solution
  • Exceeded greater than 30% savings in year 1
  • Turnover reduced to less than 8%