AstraZeneca: The CTMS CRA Experience

This video provides an in-depth exploration of AstraZeneca's strategy for achieving high end-user adoption during the implementation of a cloud-based Clinical Trial Management System (CTMS), specifically utilizing the Veeva Clinical Vault platform. The discussion centers on how the pharmaceutical giant proactively engaged Clinical Research Associates (CRAs) and site-facing personnel—the primary users—throughout the entire project lifecycle, from initial evaluation to post-go-live optimization. The core philosophy driving this approach was the commitment to "doing this with them and for them," rather than imposing change "to them," recognizing that poor user experience can turn intended benefits into burdens for clinical staff. This focus on user-centric design and change management is critical for regulated systems where adoption directly impacts data quality and compliance.

AstraZeneca employed a highly structured methodology for user engagement, beginning well before vendor selection. During the evaluation process, they established focus groups composed of CRAs and global study management teams. These groups actively participated in vendor demos and, crucially, were given access to a dedicated sandbox environment for the competing CTMS platforms. This allowed end-users to gain hands-on experience, identify potential challenges, and provide scored feedback on usability and functionality. Following the selection of Veeva, these users remained involved throughout the deployment phase, helping to define and refine processes by articulating the pain points of the legacy systems and specifying desired changes, ensuring that the final configuration addressed real-world operational needs in clinical operations.

Six months post-go-live (which occurred in June of the previous year), the company reported mixed but generally positive reviews, acknowledging that managing the "change curve" is an ongoing process. While some users immediately embraced the streamlined system, others required more time to transition from established habits. To manage this transition and ensure continuous improvement, AstraZeneca established a rapid feedback loop. Three months after launch, they deployed a comprehensive survey to their site monitoring community across 38 countries, achieving an impressive response rate of 60% or more. This feedback was immediately channeled back into the development cycle, demonstrating a commitment to agile iteration even within a regulated environment.

The feedback highlighted several areas of significant improvement for CRAs. One key enhancement was the introduction of the "user tasks" functionality, a new feature that helps track activities directly within the platform, moving task management away from external tools like email. Users also appreciated the single, unified interface provided by the Vault platform, which offers single sign-on across applications and allows for seamless navigation between milestones, documents, and other tracking elements. Importantly, the feedback often centered on minor configuration changes—such as converting a "yes/no" dropdown to a radio button—which, despite their simplicity, had a major positive impact on user efficiency. AstraZeneca’s dedicated platform team, consisting of both business and IT staff, has established a rapid cadence of internal releases (three major and eight minor releases in the post-go-live period) to quickly incorporate these small but impactful user-suggested improvements into the platform.

Key Takeaways:

• Prioritize User-Centric Implementation: Successful CTMS deployment requires engaging end-users (CRAs, monitors, study managers) early and often, treating the implementation as a collaborative effort ("with them and for them") rather than a mandate imposed upon them.
• Utilize Sandbox Environments for Evaluation: Providing end-users with hands-on access to sandbox environments during the vendor evaluation phase allows them to test usability and functionality in a low-stakes setting, resulting in more informed selection decisions and better initial buy-in.
• Integrate User Feedback into Configuration: Involve key user groups in defining the "to-be" processes by identifying pain points in legacy systems and specifying desired changes, ensuring the new system configuration directly addresses operational inefficiencies.
• Expect and Manage the Change Curve: Acknowledge that user adoption will be mixed initially; while some users will immediately find the new system streamlined, others will require time and guidance to transition from old ways of working, particularly those who have used the previous system for a long time.
• Establish a Rapid Feedback Cadence: Deploying a comprehensive user survey shortly after go-live (AstraZeneca achieved a 60%+ response rate three months post-launch across 38 countries) provides actionable data for immediate system optimization.
• Small Changes Yield Big Impact: User feedback often focuses on minor configuration tweaks (e.g., changing input methods like dropdowns to radio buttons); these small, quality-of-life improvements can significantly enhance user experience and efficiency.
• Leverage Platform Features for Task Management: The "user tasks" functionality within the CTMS is a critical feature for streamlining operations, helping to move tracking activities and communications away from unmanaged external channels like email.
• Value a Single, Unified Interface: Users highly appreciate the benefits of a single sign-on and unified interface (like the Veeva Vault platform), which allows seamless navigation between core functionalities (milestones, documents, tasks) without clicking between multiple disparate applications.
• Maintain a Dedicated Platform Team: Having a dedicated internal team (comprising both business and IT expertise) is essential for maintaining a rapid release cadence (AstraZeneca reported three major and eight minor releases post-go-live) necessary to quickly implement user-suggested changes.
• Consult with the Vendor on Configuration: Utilize the vendor (e.g., Veeva) as a resource to bounce ideas off and seek advice on the best configuration approach for specific user requirements, ensuring changes are implemented in the most effective and streamlined manner.

Tools/Resources Mentioned:

• Veeva Clinic Vault Platform: The overarching cloud platform used for clinical operations.
• Veeva CTMS (Clinical Trial Management System): The specific application within the Vault platform being implemented.

Key Concepts:

• CRA (Clinical Research Associate) / Monitor: Site-facing personnel responsible for monitoring clinical trials, ensuring compliance, and managing data quality at investigative sites. They are the primary end-users of the CTMS.
• CTMS (Clinical Trial Management System): Software designed to manage and track the planning, execution, and reporting of clinical trials, including site information, milestones, and monitoring activities.
• Sandbox Environment: A testing or development environment that isolates changes from the live production system, used here to allow end-users to safely "play around" with the system during the evaluation phase.
• Change Curve: The psychological process individuals go through when adapting to significant organizational change, often involving initial resistance followed by exploration and eventual commitment.