We offer Sponsors and CROs a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of Investigational Products. Underpinned by Central Statistical Monitoring, a technique that’s currently being investigated by the Food and Drug Administration (FDA) for selecting sites for inspection, our cloud-based products are deployed to support traditional onsite monitoring, medical review and quality to drive a Risk-Based Approach to Study Execution (RBx) and ultimately, to achieve ICH E6 (R2) compliance.
