Risk-based monitoring is coming into its own as an effective and pragmatic methodology to enhance patient safety while delivering significant efficiency benefits through reduced costs and better utilization of resources.
This white paper examines the current state of risk-based monitoring and builds on the extensive work done by TransCelerate BioPharma as well as regulatory authorities worldwide. It reviews the limitations of current eClinical technology to support the monitoring best practices called for, and why sponsors and CROs are shifting to comprehensive, real-time analytics – integrated with trial management, mobility, and data from any standards-based EDC system – as the technology backbone to effectively conduct a strategic risk-based monitoring program.
