ArborSys consultants worked side-by-side with the clinical operations and technology associates of a global pharmaceutical company on a multi-year initiative to improve business process performance and cycle times across a large number of end-to-end business processes. The team identified a number of Risk-Based Monitoring (RBM) projects. The initial project selected was a dashboard to use for risk-scoring and forecasting of onsite monitoring visits. The objective was to deliver an automated tool for risk analysis and dynamic adaptive response.
The RBM Project Team focused on building quality into the process from the very beginning. Business process experts were gathered from across the organization. Using ArborSys’ structured approach, the existing processes were documented and new streamlined, harmonized processes were developed.
Utilizing the client’s BPM software, Appian, team members were able to quickly adopt new automated routines by using the RBM Dashboard. The solution used automated risk scoring to predict the need for on-site monitoring visits, and to identify the risks that need to be addressed while monitoring a site. The initial implementation included nine Quality Risk Indicators (QRIs) for the purpose of risk identification, reporting, and notification.
The dashboard incorporated functionality matching current RBM methodology as outlined by the FDA. This allowed the user to:
The diagram below represents the long-term vision of the RBM application.
The benefits of the RBM application included:
Major business goals achieved were:
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