Leveraging AI to Streamline SAE and SUSAR Management in Clinical Trials

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.