At the 2025 Veeva R&D and Quality Summit, Sanofi unveiled a transformative approach to study training within clinical operations, emphasizing enhanced site engagement and operational efficiency. This initiative, part of a broader transformation program, aims to streamline processes and reduce costs, setting a new standard for clinical trial management. The conference highlighted Sanofi’s strategic implementation of Veeva Study Training, offering valuable insights into the future of clinical operations and digital transformation in the industry.

The Need for Transformation

Sanofi’s transformation journey was driven by the need to improve site engagement and operational efficiency, two critical challenges in the clinical trials industry. The complexity of managing multiple sites and ensuring compliance often hinders progress, prompting Sanofi to implement Veeva Study Training. The system is designed to centralize training processes, reduce costs, and transition from multiple disparate systems to a single platform. By prioritizing study training, Sanofi aimed to achieve a 30% training cost reduction through the implementation of this system, reflecting a broader industry trend toward digital transformation and efficiency in clinical operations. The decision to focus on study training leveraged to achieve early success, paving the way for subsequent digital transformation initiatives, including implementation of additional Veeva Clinical Operations applications.

Implementation Strategy

In collaboration with Veeva Business Consulting, Sanofi’s implementation of Veeva Study Training was a meticulously planned process, taking nine months from conception to rollout. The project team adopted a phased approach, initially deploying the system to internal users before extending it to site investigators. By avoiding customization, Sanofi ensured the system could easily integrate with existing processes and benefit from regular updates with minimal disruption. This approach aligns with best practices in system implementation, where maintaining standard configurations can reduce complexity and enhance system reliability.

The partnership with Veeva was crucial in navigating the implementation challenges. Veeva provided advisory support and helped organize the program governance, working closely with Sanofi to define future processes and manage change. This collaboration underscores the significance of strategic partnerships in driving successful digital transformations within clinical operations. By working together, Sanofi and Veeva were able to address challenges and accelerate the implementation process, ensuring the system’s success.

Role of the Study Training Manager

Due to enhanced efficiencies in training deployment and management, Sanofi introduced a new role: the Study Training Manager. This role was created to optimize training activities and enhance the user experience during the study startup process. The Study Training Manager is responsible for defining training strategies, managing the rollout of training sessions, and providing first-line support to users. This role ensures consistency and quality across studies, allowing Global Study Managers (GSMs) to focus on their core responsibilities. The system’s features, such as role- and responsibility-based training assignments and dynamic reporting, support this streamlined approach.

For instance, the training matrix streamlines the assignment process by automatically assigning training based on user roles and responsibilities. This feature is particularly beneficial when new team members join a study, as it ensures they receive the necessary training without delay. Additionally, the system’s dashboards provide real-time overviews of training status, enabling efficient monitoring and management of training activities. The Study Training Manager role exemplifies a shift towards specialized roles in clinical operations, where dedicated teams manage specific aspects of study management and clinical trial quality.

Initial Outcomes and Future Vision

Since its implementation, Sanofi’s study training system has demonstrated promising results. Sanofi anticipates a 30% reduction in training costs by 2025, with scalable adoption, as evidenced by 21 active studies, over 1,000 users, and the completion of 5,500 training sessions. The impact on site engagement has been significant, with simplified documentation and improved collaboration between site staff and study teams. Site staff have reported a more streamlined experience, allowing them to focus more on patient care and less on administrative tasks.

Looking ahead, Sanofi plans to expand the Study Training Manager team and enhance system functionalities. Future enhancements include improving the training matrix and optimizing reports for site staff. Sanofi also intends to continue implementing other clinical operations applications, such as Veeva Study Startup and Veeva Site Connect, into the unified platform. This vision reflects a commitment to continuous improvement and innovation in clinical operations, setting a benchmark for the industry. By building on the success of the study training system, Sanofi aims to enhance efficiency and engagement in clinical trials further, ultimately benefiting patients and stakeholders.

Addressing Challenges and Feedback

During the Q&A session, several challenges and questions were addressed, providing valuable insights into the system’s implementation and operation. One of the key challenges discussed was the integration of different training platforms and the management of training compliance. Veeva Study Training supports various training formats, including documents, videos, and eLearning modules, ensuring flexibility and adaptability to different training needs. The feedback from site staff has been overwhelmingly positive, with users appreciating the streamlined and user-friendly experience. However, some challenges remain, including managing user access and ensuring compliance across multiple sites. Sanofi continues to refine the system based on user feedback and evolving needs, demonstrating a commitment to continuous improvement and user satisfaction.

Conclusion

Sanofi’s presentation at the Veeva R&D and Quality Summit highlighted the importance of innovation and strategic planning in clinical operations. By prioritizing study training within their transformation program and collaborating with Veeva Business Consulting to develop a plan, Sanofi has established a precedent for effective change management, leading to increased efficiency and engagement in clinical trials. The insights shared at the conference provide valuable lessons for other organizations looking to improve their clinical operations through technology and strategic partnerships. As the industry continues to evolve, Sanofi’s approach serves as a model for leveraging digital transformation to improve clinical trial management and ultimately benefit patients and stakeholders.

This article is sponsored by Veeva Systems

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Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.