Mid-Sized Biotech Company
- 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
- 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)
- 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