AstraZeneca: Making the Case to Replace Legacy CTMS

This video provides an in-depth exploration of AstraZeneca’s strategic decision and execution process for replacing its legacy Clinical Trial Management System (CTMS). The primary motivation for this large-scale program was the need to streamline operations, reduce the number of disparate clinical systems, and unify various platforms into a cohesive, modern ecosystem. This journey, which began with initial conversations over three years prior to the discussion, was driven by the recognition that the existing system environment was overly complex and hindered efficiency for end-users across the business.

AstraZeneca transitioned from the Impact CTMS, a platform that had served its purpose but lacked the modern capabilities required for future growth. A key factor in selecting the new platform was the opportunity for continuous improvement provided by the vendor’s regular releases and updates—a feature that was not initially on the radar but proved highly valuable. When evaluating providers, the company looked for unified system offerings and robust future roadmaps, initially considering the entire scope of the R&D value chain before focusing the implementation down to the clinical perspective. The core technical requirement was the integration of greater automation capabilities within the new CTMS to enhance operational efficiency.

The replacement project was recognized internally as a massive undertaking, often referred to as performing a "heart and almost lung transplant" for the company. The legacy CTMS was a 20-year-old system, tightly embedded within the organization, containing vast amounts of data, and integrated with approximately 45 different external systems. This complexity naturally generated nervousness, but there was a strong internal appetite for modernization. To secure approval, AstraZeneca needed to construct a robust business case that went beyond simple cost analysis.

The methodology for building the business case involved extensive engagement with end-users, particularly clinical monitors. The team conducted deep dives to quantify current pain points, measure the exact time taken to complete specific activities within the old environment, and assign a corresponding dollar cost to those efforts. This baseline was then compared against the opportunities presented by the new Veeva clinical Vault Suite. The business case forecasted significant time savings by leveraging the platform’s automation features, particularly in monitoring activities and document management, utilizing the full capabilities of the integrated suite. Crucially, the final business case emphasized not only the projected dollar savings and implementation costs but also the qualitative metric of improving end-user satisfaction and experience, recognizing that operational efficiency and user morale are intertwined.

Key Takeaways:

• Strategic Driver: System Unification: The primary impetus for replacing the legacy CTMS was the strategic goal of reducing the number of clinical systems and unifying disparate platforms into a single, streamlined ecosystem to improve end-user efficiency.
• Legacy System Risk Quantification: The replacement of a 20-year-old system, described as the company’s "heart," required careful risk management due to its tight integration with 45 different external systems and the massive volume of historical data it contained.
• Focus on Automation as ROI Driver: A core requirement for the new system was increased automation, specifically targeting time-intensive activities such as clinical monitoring and document management, which formed the basis for calculating projected time and cost savings.
• Vendor Selection Criteria (Roadmap & Releases): Beyond current features, AstraZeneca prioritized vendors (like Veeva) that offered a clear future roadmap and committed to regular releases and updates, ensuring the platform would remain modern and adaptable over time.
• Business Case Methodology: Quantifying Pain Points: The business case was built on granular data derived from end-user engagement, specifically conducting deep dives with monitors to measure the exact time and dollar cost associated with current, inefficient processes.
• Scope Management: While the initial vision encompassed the entire R&D value chain, the implementation scope was strategically narrowed to focus specifically on clinical operations (CTMS), allowing for a manageable and successful initial deployment.
• Non-Financial Value Proposition: The final business case included end-user satisfaction and experience as a key component, recognizing that improved user morale and streamlined workflows are essential long-term benefits alongside financial savings.
• Leveraging Integrated Suites: The decision to move to the Veeva platform was driven by the capability of utilizing the full Vault Suite, integrating CTMS functionality with document management capabilities to maximize operational synergy.
• Appetite for Modernization: Despite the inherent nervousness surrounding a major system replacement, there was a strong organizational appetite for moving away from the legacy platform toward a more modern solution.

Tools/Resources Mentioned:

• Veeva clinical Vault Suite: The modern platform selected to replace the legacy system, emphasizing its integrated capabilities for clinical operations and document management.
• Impact CTMS: The 20-year-old legacy Clinical Trial Management System that was replaced.

Key Concepts:

• CTMS (Clinical Trial Management System): Enterprise software used by pharmaceutical and biotech companies to manage and track the planning, execution, and reporting of clinical trials.
• Unified Ecosystem/Platform Unification: The strategic goal of consolidating multiple, disparate software systems into a single, integrated platform to reduce complexity and improve data flow.
• Legacy System Replacement: The complex process of decommissioning an older, deeply embedded system (in this case, 20 years old) and migrating its data and integrations to a modern platform.
• End-User Satisfaction: A critical qualitative metric used in the business case to measure the success of a technology implementation, focusing on how the change improves the daily workflow and experience of the system’s users.