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