Novartis: AWS/Accenture AI-Powered Clinical Trial Transformation

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Novartis: AWS/Accenture AI-Powered Clinical Trial Transformation

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Novartis partnered with AWS Professional Services and Accenture to modernize their drug development infrastructure and integrate AI across clinical trials with the ambitious goal of reducing trial development cycles by at least six months. The initiative involved building a next-generation GXP-compliant data platform on AWS that consolidates fragmented data from multiple domains, implements data mesh architecture with self-service capabilities, and enables AI use cases including protocol generation and an intelligent decision system (digital twin). Early results from the patient safety domain showed 72% query speed improvements, 60% storage cost reduction, and 160+ hours of manual work eliminated per month. The protocol generation use case achieved 83-87% acceleration in producing compliant protocols, demonstrating significant progress toward their goal of bringing life-saving medicines to patients faster. Led by Anna Klebus, Head of Data, Digital and IT for Drug Development at Novartis, the initiative adopted three key architectural principles: Modularity (plug-and-play AI components), Balanced Portfolio (mixing quick wins with moonshot projects), and Ruthless Prioritization (focusing resources on high-impact initiatives). The platform follows data mesh architecture, enabling AI use cases across protocol generation, intelligent decision systems (digital twin), and document automation. The GXP-compliant environment ensures data integrity, security, and traceability for regulatory requirements. Key AI use cases include: Protocol Generation (83-87% acceleration in generating regulatory-compliant protocols), Intelligent Decision System (computational digital twin for clinical trial simulation), and Document Generation (across clinical study reports and medical affairs).