Standards-Driven and AI-Driven Automation in Clinical Data Flows

Abstract

This study explores how standards-driven and AI-driven automation can streamline the clinical data flow at AstraZeneca (AZ) and improve interoperability within the healthcare industry. As clinical data volumes and complexity increase, efficient management of data is critical for accelerating drug development while ensuring robust clinical evidence. The study maps AZ’s current clinical data flow and identifies opportunities for automation and standardization. A qualitative research method was applied, using semi-structured interviews with AZ employees and an internal documentation review. Process mapping and thematic analysis were conducted to generate a Data Flow Diagram, extract key insights, and deliver recommendations. Findings show that the current data flow involves several manual steps across data collection, management, statistical analysis, and regulatory submission. Key areas for improvement include stricter metadata requirements, a centralized data flow, and detailed workflow documentation to support automation. The study also highlights the potential of machine-readable specifications and executable metadata, aligned with the Clinical Data Interchange Standards Consortium 360Implementation (CDISC 360i) program, to enable platform-based, streamlined data flows. Prioritizing critical-to-quality data in study protocols and shifting to structured, data-centric regulatory submissions are recommended. Several AI opportunities were identified, including digital twins for virtual control arms, natural language processing for regulatory text generation, and agentic AI for end-to-end automation. These require strong quality control, human oversight, explainability, and regulatory acceptance. The study concludes that by proactively adopting these recommendations, AZ can improve internal efficiency, support a connected and data-driven healthcare ecosystem, and help lead the transformation toward faster, higher-quality drug development and timely patient access to innovative treatments.