KPS Approach To Quality Oversight Visits

Co-Monitoring Visits (Monitoring Oversight) Sponsors and CROs employ CRAs to monitor clinical study sites. Because most site monitoring is done in the field, it is challenging for study managers to know and understand if CRAs/monitors are conducting their duties...

On-Time Database Lock

On-Time Database Lock Problem Utilization of mid-sized CRO; repeated milestone delays generated initial concern. Upon random Sponsor review, issues were identified at the site that were not denoted on the monitoring trip report. Sponsor was in need of inspection...

QC/Vendor Oversight Program

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...

Large Pharmaceutical Company

Large Pharmaceutical Company Problem Sponsor utilizing CRO for global Clinical Monitoring support CRO monitoring team had high turnover rate > 30%, inexperienced CRAs and 2 Project Managers assigned within 4 months due to turnover. Need to contain costs in...