Plan: Identify study-specific critical data, processes and associated risks, and assigning a risk severity score to build adequate mitigation controls.
Build: Creating a detailed Integrated Risk Plan (IRP) for cross-functional study teams to draft, review, finalize, and approve.
Surveillance: Data-driven surveillance across all study dimensions- patient, site, study, and quality tolerance limits.
Review: Facilitates signal management for study teams to create, manage, follow up, and action the risk signals identified, followed by an update of the Risk Inventory (RI).
Report: An automated tool integrating inputs from all previous modules through a “push-down” mechanism to generate reports and enabling study teams to review the final integrated risk plan (IRP), final Risk Inventory (RI), and signal summaries.