CluePoints’ ground-breaking Site Inspection Readiness service, RADARTM, enables sponsors to achieve a data-quality driven understanding of risk upon which to base high-impact site inspection readiness activities. Our Data Analysts will undertake a comprehensive statistical analysis of all study data using CluePoints’ Central Statistical Monitoring Platform, to provide an inspection readiness report. This is fully aligned with FDA’s own approach to selecting sites for inspection based on data quality assessment.
Identify sites and patients ‘at risk’ based on objective statistical results, unlike any other Site Inspection Readiness service
Produce a ranking of study sites by their risk severity, highlighting key discrepancies and anomalies across site and patient data
Obtain targeted lists of Clinical Data Signals for review
Achieve full traceability via an auditable and documented process