Metrics You Can Rely On

The transparency that underlies our methods serves to instill confidence in clinical trial operations. In accessing the trial meta-data, stakeholders can see how standard operating procedures (SOPs) are operationalized in the trial. The integration of clinical and meta-data within a single system delivers a more comprehensive picture of the overall conduct of the trial. The use of technology thus enhances quality control and project efficiency; but also makes the evidence of these artifacts easily manifest through the use of performance metrics, such as:

Site Activation

• Cycle time to site qualification
• Cycle time to first site activated
• Cycle time to site activated
• Regulatory pack approval rate
• Percent planned sites activated

Site Performance

• Cycle time from activation to first patient first visit (FPFV)
• Site productivity (% meeting goals)
• Screen failure rate
• Patient accrual
• Patient drop out rate

Data Quality

• Cycle time to CRF data entry
• Data discrepancies
• Query response time
• Source data verification

Close Out

• Cycle time for query resolution
• Cycle time from last patient last visit (LPLV) to data lock
• Cycle time to site close out
• Issue identification & resolution