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

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%