QC / Vendor Oversight Program
Problem
- 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
Solution
- 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
Results
- 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