AstraZeneca’s Journey Towards Unified Clinical Operations

Clinical operations leaders filled the room at Veeva R&D Summit Europe to hear Debbie Brook from AstraZeneca describe the organization’s clinical transformation and their vision for 2021. She detailed their move to a unified suite, success criteria, and change management considerations for successful global adoption.

The Challenges

When Debbie was assigned to this initiative, AstraZeneca was using legacy CTMS technology that was not adaptive to today’s clinical trials and was difficult to integrate with other clinical systems. She found that the 45 existing integrations and business processes were based on the limitations of the CTMS application, rather than on the desired optimal processes for the business. As a result, AstraZeneca’s clinical operations teams were using spreadsheets and emails for tracking and reporting, increasing inefficiencies, duplicating data entry, and providing limited visibility across clinical trials.

With the implementation of Vault Clinical to unify the CTMS, eTMF and incorporate study start-up capabilities as well as review of overall processes, AstraZeneca expects to eliminate non-business critical processes, and reduce integrations and maintenance by 40%. By unifying all clinical operations processes, AstraZeneca will break down data silos, improve data quality, and provide end-to-end visibility into trial activities from study planning to closure.

Study start-up was one of the areas that will benefit the most from the clinical operations transformation, helping to streamline the processes and lead to faster activation of our sites in trials to support the vision to get medicines to our patients faster. In the absence of purpose-built applications for study start-up, global clinical teams had custom-built spreadsheets and processes to address region-specific needs and to provide the level of granularity required to ensure all requirements for site activation were achieved. With the ability to manage initiation and activation processes in one application, AstraZeneca expects improved visibility, transparency, and inspection readiness with the study start-up functionality linking documents to milestones and a reduction in the use of custom-built spreadsheets and processes by 80%. Streamlining of monitoring visit report writing is another area that will benefit from the use of a single application. With the ability to automate much of the report writing within the platform through improved integrations and single point of entry for monitoring trip report information, AstraZeneca expects to reduce monitoring report completion by at least 50%.

Lessons Learned

The key to AstraZeneca’s successful system adoption across 40+ countries entailed the early involvement of monitors and study leads to help define the global processes and country-specific requirements needed for application configuration. This approach provided study teams with the global visibility to drive process standardization and the ownership to drive internal change.

Debbie also mentioned the importance of implementing a ‘train the trainer’ approach when taking on large-scale, global initiatives. The importance of aligning people, processes, and technology cannot be understated as are the soft skills required to bring people on board when multiple changes are hitting them at once.

Next Steps

AstraZeneca currently uses Vault eTMF and continues to implement the full Vault Clinical Operations Suite to include Vault CTMS and Vault Study Startup, with implementation expected to be complete by early 2020.

Read the 2020 Unified Clinical Operations Survey Report for research and analysis on the evolving clinical trial technology landscape.