--- title: "Leveraging AI to Streamline SAE and SUSAR Management in Clinical Trials" description: "Clinical trial safety teams are under increasing pressure. Larger global studies, decentralised trials and growing volumes of safety data make timely SAE and SUSAR management more complex than ever. Artificial Intelligence offers powerful opportunities to improve efficiency across pharmacovigilance workflows, but successful implementation requires more than technology alone. Regulatory compliance, human oversight and inspection readiness remain essential. This white paper explores where AI delivers genuine value today, where the risks lie, and how sponsors and CROs can introduce AI responsibly within existing regulatory frameworks." url: https://qbdgroup.com/en/downloads/ai-sae-susar-management-clinical-trials type: "White paper" language: en published: 2026-07-08 author: "Anam Ahmad" category: "Clinical" publisher: "QbD Group" citation: "QbD Group, \"Leveraging AI to Streamline SAE and SUSAR Management in Clinical Trials\", https://qbdgroup.com/en/downloads/ai-sae-susar-management-clinical-trials" --- # Leveraging AI to Streamline SAE and SUSAR Management in Clinical Trials > Clinical trial safety teams are under increasing pressure. Larger global studies, decentralised trials and growing volumes of safety data make timely SAE and SUSAR management more complex than ever. Artificial Intelligence offers powerful opportunities to improve efficiency across pharmacovigilance workflows, but successful implementation requires more than technology alone. Regulatory compliance, human oversight and inspection readiness remain essential. This white paper explores where AI delivers genuine value today, where the risks lie, and how sponsors and CROs can introduce AI responsibly within existing regulatory frameworks. ## About this white paper Artificial Intelligence is rapidly becoming part of everyday pharmacovigilance operations. From automated case intake and data extraction to narrative drafting and intelligent case prioritisation, AI can significantly reduce manual workload across clinical safety teams. At the same time, organisations face growing regulatory expectations around transparency, validation, explainability and governance. Understanding where AI can safely support clinical trial safety, and where human expertise must remain central, is becoming increasingly important. This white paper provides a practical overview of current AI applications in SAE and SUSAR management, discusses the associated compliance risks, and explains how organisations can prepare for evolving regulatory expectations across the EU and UK. ## Key Takeaways - How AI is already supporting SAE and SUSAR management across clinical trials - Which pharmacovigilance activities benefit most from machine learning and generative AI - Why human oversight remains essential despite increasing automation - The biggest governance risks, including automation bias, explainability and model drift - How GDPR, the EU AI Act and current GCP expectations influence AI adoption - Best practices for validation, inspection readiness and AI governance - Practical recommendations for sponsors and CROs implementing AI-enabled safety workflows ## Download this white paper Complete the form on this page to receive your copy. --- Source: https://qbdgroup.com/en/downloads/ai-sae-susar-management-clinical-trials — © QbD Group. Quote freely with attribution and a link back.