AstraZeneca: Clinical Transformation Journey Overview

This video provides an in-depth exploration of AstraZeneca's multi-year clinical transformation journey, focusing on enhancing trial efficiency, speed, and quality through digital innovation. Debbie, representing AstraZeneca, outlines the strategic imperatives that drove this initiative, which began approximately three years prior, aiming to fundamentally reimagine their ways of working for clinical trials. The core objective was to simplify and streamline processes, redefine clinical trials through digital health, and ultimately improve patient outcomes and experiences, aligning with their "Patients First" value.

A central theme of AstraZeneca's transformation was the simplification of their complex system landscape, which they metaphorically described as moving from a "spaghetti of systems" to a more organized "lasagna" architecture. Initially, they grappled with disparate, poorly integrated systems that necessitated duplicate data entry, leading to inconsistencies and delays in information transfer. Their future vision involved a unified, streamlined architecture with a central data hub or platform, fed by foundational source systems like Veeva Clinical Vault. This approach aims to establish a single source of truth, eliminating redundant data entry and enabling the application of advanced and predictive analytics for data-driven design, predictive decision-making, and patient-facing tools.

The transformation project yielded several key solutions designed to optimize various aspects of clinical development. These included "Merlin," a digital and analytics solution focused on study design, leveraging data to inform scientific and operational design, reduce study costs, and facilitate faster, data-driven site selection by integrating electronic health records. Another critical component was the "Control Tower," a visualization tool that pulls data from the central platform to apply advanced and predictive analytics for real-time study performance monitoring. This system helps identify potential risks early, enabling timely course correction and significantly reducing reliance on manual spreadsheet tracking, with an estimated automation of 400,000 hours of manual reporting. Additionally, efforts were made to optimize clinical supply forecasting, aiming to reduce design waste from 50% to 20%, eliminate 5,000 shipments, and save approximately $120 million, while also advancing sustainability objectives.

Finally, a cornerstone of this transformation was the adoption of a unified clinical system, with Veeva Clinical Vault serving as a foundational platform. This represented AstraZeneca's most significant clinical system change in two decades. The goal was to create a single entry point for data, managing and executing clinical trials from start to closeout on one platform. By leveraging their existing Veeva eTMF capabilities and integrating new modules like CTMS and Study Startup, AstraZeneca achieved a seamless user experience across different functionalities. This unified approach enhances transparency for global and local study teams, streamlines operations through automation, and significantly improves inspection readiness by combining document management (TMF) with milestone tracking and study startup functionality.

Key Takeaways:

• Strategic System Simplification: AstraZeneca successfully embarked on a journey to untangle a complex "spaghetti of systems" into a more unified "lasagna" architecture, highlighting the critical need for system landscape simplification in large pharmaceutical organizations to improve efficiency and data integrity.
• Centralized Data Platform: The establishment of a central data hub or platform is paramount for achieving a single source of truth, eliminating duplicate data entry, and ensuring consistency across various clinical systems. This foundational element enables advanced analytics and data-driven decision-making.
• Leveraging Advanced and Predictive Analytics: The transformation emphasizes the power of advanced and predictive analytics for data-driven study design (e.g., Merlin), real-time performance monitoring (e.g., Control Tower), and predictive decision-making, moving beyond reactive management to proactive intervention.
• Significant Automation Potential: The "Control Tower" solution alone is projected to automate approximately 400,000 hours of manual reporting previously performed by study teams, underscoring the immense efficiency gains achievable through digital transformation and automation in clinical operations.
• Integrated Veeva Ecosystem: AstraZeneca strategically leveraged its existing investment in Veeva eTMF by integrating additional Veeva Clinical Vault modules (CTMS, Study Startup) to create a unified clinical platform. This demonstrates the value of building upon existing enterprise solutions to expand capabilities.
• Seamless User Experience: A key design principle was to ensure end-users perceive a single, seamless interface when navigating between different modules within the Veeva Clinical Vault suite, enhancing user adoption and reducing operational friction.
• Improved Inspection Readiness: By unifying document management (eTMF) with study milestones and startup functionalities on a single platform, AstraZeneca significantly improved data transparency and quality, directly contributing to better inspection readiness and regulatory compliance.
• Data-Driven Study Design and Site Selection: The "Merlin" solution showcases how digital tools and analytics can drive more informed study design, reduce time and costs, and enable faster, data-driven site selection by integrating diverse data sources, including electronic health records.
• Optimized Clinical Supply Chain: The project addressed clinical supply chain inefficiencies, aiming to reduce design waste from 50% to 20% and eliminate 5,000 shipments, leading to substantial cost savings ($120 million) and contributing to organizational sustainability goals.
• Shift from Static to Real-time Data: The move away from manual tracking in static spreadsheets to real-time, live data within integrated systems provides up-to-date views of study status, enabling more agile risk mitigation and course correction.
• Patient-Centric Digital Solutions: All transformation efforts are underpinned by the overarching goal of improving outcomes and experiences for patients, with the development of patient-facing tools as a direct outcome of the data platform and analytics capabilities.
• Long-term Organizational Change: The initiative represents a significant organizational change for AstraZeneca, described as the biggest clinical system change in 20 years, highlighting the scale and commitment required for such a comprehensive digital transformation.

Tools/Resources Mentioned:

• Veeva Clinical Vault
• Veeva eTMF (Electronic Trial Master File)
• Veeva CTMS (Clinical Trial Management System)
• Veeva Study Startup
• Merlin (AstraZeneca's internal solution for study design)
• Control Tower (AstraZeneca's internal visualization tool for performance monitoring)

Key Concepts:

• Spaghetti of Systems: A metaphor used to describe a highly complex, poorly integrated, and disparate collection of IT systems within an organization.
• Lasagna Architecture: A metaphor for a more unified, streamlined, and layered IT architecture, implying better organization and integration compared to a "spaghetti of systems."
• Data Hub/Data Platform: A centralized repository and processing system for data from various source systems, designed to create a single, consistent view of information.
• Single Source of Truth: A concept in data management where all data elements are stored exactly once, preventing inconsistencies and ensuring data integrity across an organization.
• Data-Driven Design: An approach to designing clinical studies and operations based on insights derived from data analysis rather than assumptions or traditional methods.
• Predictive Analytics: The use of data, statistical algorithms, and machine learning techniques to identify the likelihood of future outcomes based on historical data.
• Inspection Readiness: The state of being prepared to demonstrate compliance with regulatory requirements during an audit or inspection, often facilitated by organized and accessible data and documentation.

Examples/Case Studies:

• AstraZeneca's 3-Year Clinical Transformation: The entire video serves as a case study of AstraZeneca's journey to modernize its clinical operations.
• Automation of 400,000 Hours: A specific example of efficiency gain, demonstrating the potential for automating manual reporting tasks through the "Control Tower" system.
• $120 Million Savings in Supply Chain: A concrete financial benefit achieved through optimizing clinical supply forecasting and reducing design waste.