Clinical Trial Risk Management with Xcellerate RBQM

This case study presents an evaluation of the Xcellerate® Risk-Based Quality Management (RBQM) solution by Fortrea, aimed at enhancing clinical trial risk identification and management for a biopharmaceutical sponsor. The sponsor sought to improve productivity and reduce costs through digital automation tools, specifically by leveraging the capabilities of the Fortrea Intelligent Technology™ suite. The study outlines how Xcellerate® RBQM utilizes natural language processing and machine learning to automate the risk identification process, thereby addressing inefficiencies associated with manual risk assessment. By analyzing key study documents and comparing them against a risk knowledge base, the solution surfaces relevant risks and provides rationale-based suggestions for risk management. The implementation of Xcellerate® RBQM is expected to lead to improved quality metrics, reduced protocol amendments, and significant cost savings, ultimately enhancing patient safety and data integrity throughout the clinical trial process.