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Blog: Making it Real: Transitioning to a SaaS Safety System

Journey, Insights, and Learnings from Sanofi’s Implementation

In a recent discussion, panelists from Sanofi, Ultragenic, and ArisGlobal shared experiences relating to Sanofi’s recent implementation of a new LifeSphere system. 

Sanofi made a business decision to create a separate consumer business entity that would align with its specific objectives. As part of this decision, the company recognized the need for this entity to have its own PV database dedicated to consumer products, since Sanofi competes with brands like Nestle and Danone in the nutraceuticals and dietary supplement market, and they had to apply rigorous norms to their consumer brands. 

To succeed in this business, Sanofi also recognized the need to transform processes to meet the specific requirements of this new venture. Their current on-premise solution was deemed inadequate for the competitive market, so they concluded that a cloud-based, software-as-a-service (SaaS) solution was the only viable option. 

In pursuit of a comprehensive solution, Sanofi evaluated four different platforms from seven vendors. Their primary criteria included a SaaS module that encompassed the necessary end-to-end safety functionality, from case intake and processing through signal detection and analytics. They also emphasized the importance of automation, aiming to achieve a touchless system within five years and sought a vendor with a solution for achieving this touchless goal. 

Ultimately, they selected ArisGlobal’s LifeSphere Multivigilance 


Implementing LifeSphere Multivigilance: Transitioning to a SaaS Safety System

An ambitious implementation and kickoff goal of 12-months was set, despite some skepticism from members of the team. LifeSphere Multivigilance provided an out-of-the-box solution that met Sanofi’s objectives and timeline. These factors played a significant role in the decision-making process. 

Building the vision for collaboration with customers and partners in the industry involves more than just a roadmap. It requires a collective effort, involving an array of stakeholders, including an active and engaged customer community, advisors, product councils, and even regulators. These voices contribute to shaping the roadmap and ensuring its feasibility. However, going beyond this roadmap, the product team must find ways to make the vision a reality through continuous releases, guided by customer feedback while balancing multiple perspectives. 

The implementation phase requires a partner to serve as a bridge between the product team and the client, in this case, Sanofi. This partner assists in successfully bringing the product into operation, considering both the product’s capabilities and the client’s specific business requirements. 

The expectation was a plug-and-play system, but implementation was particularly challenging as Sanofi needed to manage 700+ products and multiple affiliates. Plus, their initial attempt to utilize more than 1,000 rules from ArisGlobal proved unsuccessful, leading to the development of new configurations requiring additional support.  

During the migration process, Sanofi received valuable assistance and insights from Ultragenic, who possessed prior knowledge of the system from which data was being migrated. This expertise helped manage data discrepancies and ensure a smoother transition. Sanofi’s setup was heavily customized, diverging significantly from the standard configuration. 

The team conducted a comprehensive “day in the life” analysis to uncover practical issues that may arise after the system goes live. They understood the importance of operational readiness prior to the system launch. Operationalizing the system involved simulating the entire environment, including the process of raising support service tickets. The in-depth, “day in the life” analysis yielded valuable insights into business processes, system functionality, and support systems, and allowed them to proactively address and resolve issues revealed by the analysis. 

Having utilized LifeSphere Multivigilance for two decades following previous implementations, the Ultragenic team regarded it as a solid and reliable solution. For Sanofi, understanding the system’s intricacies required collaboration with ArisGlobal. 

Collaboration played a critical role throughout the implementation process, which encompassed people, processes, and tools. Appointing an implementation partner offered numerous advantages, particularly in terms of optimizing the timing. While having excellent tools is essential, effectively utilizing them is key to achieving the desired outcomes. 

The close cooperation between team members was pivotal as they strived to align Sanofi’s system requirements with the system’s configuration. Coordinating with various stakeholders, including system teams, business teams, affiliates, signaling teams, and safety heads in various countries, proved crucial. Serving as a bridge between the systems team and the business team, Ultragenic expressed gratitude for the exceptional support received from Aris Global and Sanofi. 


Reflecting on a Unique Integration

Sanofi’s journey stood out for its unique aspects, such as the integration of LifeSphere MultiVigilance with their Veeva system and the challenges encountered during the migration process, including recalibrating numerous entries and products. However, they successfully achieved their objectives, with 90% of Veeva names now aligned with the regulatory database. 

While the implementation process encountered hurdles and glitches, the team tackled them through effective communication, optimism, and a commitment to continue to overcome any remaining issues through teamwork. 

Having been involved with Sanofi for many years, Ultragenic reflected on the complexity of previous implementations, emphasizing the transformative nature of each endeavor. They recalled spending considerable time at Sanofi’s office in France, working alongside the business team to find solutions to challenges. 

When prompted for advice on optimizing processes during periods of change, Ultragenic emphasized the significance of their transformation journey, transitioning from a highly customized ArisGlobal system to an out-of-the-box solution. They stressed the importance of managing expectations, engaging stakeholders, and convincing them of the benefits of an out-of-the-box system. This shift in mindset facilitated the achievement of a 99% out-of-the-box configuration within a ten-month timeframe, beating the 12-month goal. 

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Ultragenic acknowledged that the transformation from a highly customized system to a standardized one required significant effort but resulted in enhanced operational efficiency. Additional investment in partnerships could aid in further increasing the return on investment of the process by making integration easier. They advocated for comprehensive planning and leveraging partners’ expertise to navigate implementation challenges, citing the model’s long-standing success. They expressed hope for an expanded ecosystem with more partners joining to foster successful implementations. 

All parties recognized that standardization and optimization are ongoing journeys that require maturation from both a technological and adopter perspective, in addition to a commitment to remaining accountable and delivering innovative solutions that simplify users’ lives. 

Learn more about LifeSphere Multivigilance and discover how your organization can transition to a SaaS safety system. Ready to see it in action? Request a demo today.