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 close out visit.
days of close out visit
Solution
Sponsor engaged KPS to perform QC Assessment Evaluation of study 2 weeks prior to first QC Visit. KSP assembled a team of 9 CRAs within one week.
KPS completed 35 monitoring oversight visits in North America in 20 business days (one month) and wrote and submitted all visit reports to Sponsor’s CTMS system within 2 business days of the KPS visit
monitoring oversight visits in North America in 20 business days (one month)
Results
KPS engaged to work alongside Sponsor CQA for QC program design
Database Lock remained on schedule for study
Sponsor successfully passed agency Audit of compound
