Mid-Sized Biotech Company

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 readiness within 60 days of...

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...

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 monitoring force.   % turnover rate...

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