Clinical Trial Start-Up Tracker

Delays in the clinical trial start-up process, preventing timely enrollment of patients in studies, is one of the most significant causes of clinical trial failures. Trial Tracker provides governance for the clinical trial start-up life cycle, with quick visual indicators to identify process status and anticipate delays in setting up clinical trials allowing time for corrective or preventive action. Financial, electronic health record, and regulatory processes are all displayed in a straightforward format as a process “subway” graph where each node represents specific start-up steps.

Real-time data integration of multiple data sources, combined with process step status and cycle time indicators, provides researchers and clinical trial office administrators with accurate information to identify potential roadblocks. An additional administrator portal provides visualization of start-up performance metrics with several filter options for data elements and cycle time date range selections, with the ability to view all trials at once or section off by primary purposes, disease working groups, and more.

Features:

• Data Integration:
  • Electronic Medical Record
  • REDCap (research electronic data capture system)
  • Clinical trial management system
  • Clinicaltrials.gov
  • Built upon our custom enterprise Hyperion Data Platform providing data interoperability and management, with data harmonization through our Hyperion Common Data Model.
• Tracking Indicators:
  • 3 track monitoring for financial, electronic health record, and regulatory process steps.
  • Completion dates listed for each completed process step.
  • Cycle time listed between completed process steps.
  • Current active process point indicated by highlighted step and progress spinner.
• Administrative Portal Performance Metrics and Visualizations:
  • Filter by Study source, Disease working group (DWG), Researcher, and Study Status.
  • Several date range selection options including dates of medical coverage analysis (MCA), clinical trial agreement (CTA), study activation, disease working group review, and Protocol Review and Monitoring Committee submission.
  • Visualizations include study status metrics, and several cycle times sorted by researcher or study source including PRMC to Study Activation, DWG Review to Study Activation, and MCA sent to CTA.