Sanofi: Streamlining Clinical Study Training
Across the Portfolio
30%
projected savings
3
systems eliminated
10,000
users across 43 countries
Study training is a significant yet often hidden cost in clinical trials. For an average Phase 2 study with 40 sites, study training costs can exceed $200,000 ¨C assuming that everyone completes training once and correctly. With retraining, that figure can jump to $350,000.
Delphine Maillard, head of clinical learning and development at Sanofi, knew these challenges well. As a top 10 biopharma with over 80,000 employees, Sanofi lacked an internal system to train site staff. Instead, Maillard¡¯s team relied on multiple, disparate systems provided by service providers.
¡°When you don¡¯t have a centralized system, it¡¯s not possible to reconcile all the training information. Ultimately, that is what brought us to ³Ô¹Ï±¬ÁÏ Study Training,¡± explains Maillard. Since consolidating three previous systems into a single platform, the company is on track to reduce study training costs by an estimated 30%.
Saving time with automated study training workflows
Maillard points to several ³Ô¹Ï±¬ÁÏ Study Training capabilities that help Sanofi save time and improve oversight:
- Training matrix: Team members can automatically assign training based on user roles and responsibilities. This is especially helpful when new team members join a study, ensuring they receive the necessary training without delay. ¡°You can create a draft of the training matrix, then study managers approve roles and training assignments. Once validated, the system automatically sends notifications to learners,¡± says Maillard.
- Crosslink with eTMF: When a study manager uploads a document in ³Ô¹Ï±¬ÁÏ eTMF, they can also send it to ³Ô¹Ï±¬ÁÏ Study Training. The system automatically creates the training environment, assigns it through the training matrix, and notifies users. ¡°It¡¯s very quick and easy,¡± Maillard notes.
- Dynamic dashboards and reports: Real-time dashboards provide visibility into training status, metrics, and activities across studies.
A quick-win to kick off Sanofi¡¯s clinical transformation
For Sanofi, implementing ³Ô¹Ï±¬ÁÏ Study Training was part of a broader initiative to reshape clinical operations. Five years ago, the company began implementing the ³Ô¹Ï±¬ÁÏ Clinical Operations Platform, starting with ³Ô¹Ï±¬ÁÏ eTMF followed by ³Ô¹Ï±¬ÁÏ Study Training.
¡°We needed a quick win to kick off our multi-year transformation ¨C and ³Ô¹Ï±¬ÁÏ Study Training was just that,¡± says Maillard.
Sanofi deployed the system to internal users in nine months and went live with site staff just two months later. More than 10,000 users based in 43 countries ¨C including 8,000 site staff members ¨C have access to the system. The company has already completed over 128,000 total training assignments.
¡°It makes life much easier for site staff. They use one ³Ô¹Ï±¬ÁÏ login to access all Sanofi studies and receive automated notifications when training is required. The system also tracks training that repeats across studies, so site staff don¡¯t have to complete the same modules multiple times.¡±
Lessons learned from Sanofi¡¯s implementation
Sanofi partnered with ³Ô¹Ï±¬ÁÏ Business Consulting to implement Study Training in phases. For companies considering a new study training system, Maillard recommends avoiding customization wherever possible to support easier integration with existing processes.
She also emphasizes the value of a dedicated planning phase. ¡°We took time to define our project scope, implementation strategy, and operating model,¡± says Maillard. ¡°It was also an opportunity to review and harmonize our study training processes.
Piloting the ¡®study training manager¡¯ role
Like many biopharmas, Sanofi¡¯s study teams were previously responsible for managing study training. During implementation, the company piloted a new role: the study training manager (STM).
STMs define training strategies, manage rollout of the training matrix, and provide first-line support to users. They also ensure consistency and quality across studies. As a result, global study managers can focus on their core responsibilities.
Next steps on Sanofi¡¯s journey toward unified clinical
With study training standardized, Maillard¡¯s team is expanding its STM program and plans to implement ³Ô¹Ï±¬ÁÏ CTMS, Study Startup, Site Connect, and Payments over the next few years. ¡°This journey toward centralized, compliant study training has delivered significant benefits to Sanofi, our sites, and ultimately to our patients,¡± says Maillard. ¡°By starting with Study Training, we¡¯ve established a solid foundation for future transformation initiatives.¡±
Learn how another top 10 biopharma streamlined study training and enhanced oversight.
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