Bridging Protocol Complexity and Compliance: Leveraging AI for Precision Risk Identification in Risk-Based Quality Management

About this session

This presentation introduces an AI-powered assistant designed to perform structured, protocol-driven risk identification in clinical trials. By deeply analysing study design, population, endpoints, procedures, investigational product characteristics, and vendor dependencies, the tool systematically generates GCP-aligned risk statements mapped to Critical-to-Quality factors. The approach enhances consistency, traceability, and early detection of high-impact risks, supporting proactive RBQM implementation before study start-up.

Speaker

• AC

  Alessia Cantamessa

  RBQM Strategic Lead, Pharma Development Quality · F. Hoffmann La Roche AG

  Speaker