Daunielle Chipman, Senior Director at IQVIA and Julie Girod, Associate Vice President at Sanofi, recently discussed how Sanofi’s PSPV group has optimized intake processes to manage over 700,000 adverse reactions received annually. The conversation covered the evolution of the ARTEMIS project, which utilizes AI and OCR to improve safety operations, and how a partnership with IQVIA helped Sanofi adapt and transition to a new system in less than a year, sustaining progress in digital safety innovation.

The significant increase in data sources, such as social media, has prompted the use of artificial intelligence (AI) and automation to help revolutionized pharmacovigilance (PV) practices. Organizations can now use a wider range of data sets and automation to prioritize high-value activities that improve patient safety, compliance, and the overall quality of their processes.

Sanofi’s Project ARTEMIS (Adverse Event Processing using Technology-Enabled Medical and Intelligence Solutions) initiative paints the perfect picture of how strategic partnerships and innovation are reshaping PV operations. Initiated in 2019, the program integrates advanced analytics and automation to streamline workflows and improve safety operations.

Addressing the Challenges of Pharmacovigilance

Sanofi manages over 700,000 adverse event reports annually, with case volumnegrowing 5-20% each year. Historically, traditional workflows that are reliant on manual inputs resulted in inconsistent quality, inefficiencies, and rising costs. Challenges also included maintaining compliance across a complex global framework.

The ARTEMIS program employed a phased implementation strategy to overcome these barriers. By engaging health authorities like the FDA, EMA and MHRA early on, Sanofi ensured alignment with regulatory expectations while mitigating implementation risks. This proactive engagement also fostered trust and transparency, which have been key to the program's success.

Delivering Results Through Collaboration

Sanofi’s transition to IQVIA as its key partner in 2023 helped Sanofi use a system that was better tailored to their needs with more robust functionalities. The third phase, launched in August 2024, introduced truly transcending capabilities:

• Integrated Data Processing: Automates ingestion, classification, and extraction of data from multiple sources such as email, E2B, and structured forms.
• Real-Time Analytics: Tools such as optical character recognition (OCR) and natural language processing (NLP) enhance accuracy and compliance.
• End-to-End Workflow Integration: Ensures seamless connection between intake systems and legacy safety platforms.

The primary goal is to refocus safety teams on high-value activities, such as medical review, by alleviating the heavy manual administrative burden they currently face. Additionally, AI offers the advantage of enhanced consistency, ensuring greater reliability in processes. This project achieved these outcomes through a meticulously phased approach that combined technology integration with change management strategies.

The Road Ahead

Sanofi and IQVIA are planning additional phases of automation to fully replace the legacy PV system by 2025. Key goals include:

• Global Case Management Harmonization: Unifying workflows across regions, including country-specific regulatory requirements.
• Targeted Medical Reviews: Enhancing accuracy through AI-driven assessments.
• Streamlined Timelines: Reducing case processing timelines.

Future developments also focus on incorporating smarter workflows that dynamically adapt to evolving regulatory needs. For instance, AI-driven tools will enable faster identification of critical cases, prioritizing them for immediate review, while routine cases can be processed with minimal human intervention. By leveraging these capabilities, Sanofi aims to build a scalable model that aligns with the diverse regulatory landscapes of global markets.

Lessons Learned

Sanofi’s journey offers valuable insights for organizations seeking similar transformations:

• Collaborative Leadership: Cross-functional collaboration between business and digital teams was essential.
• Phased Implementation: Incremental changes minimized risks and facilitated adaptation.
• Human Oversight: While automation drives efficiency, human expertise remains critical for compliance and ethical considerations.

These principles underscore the importance of integrating cutting-edge technologies with human expertise. By adopting a phased approach, the project enabled Sanofi to systematically tackle initial obstacles, improve processes and develop trust in AI-driven solutions.

Sanofi's crucial decision to invest in strong change management strategies has been instrumental. By keeping stakeholders informed and involved throughout the journey, the organization was able to foster alignment and ensure smooth adoption of new systems and processes.

Redefining Pharmacovigilance

In an industry where precision and efficiency are paramount, Sanofi’s partnership with IQVIA stands as a testament to the transformative power of technology and collaboration. ARTEMIS is more than a blueprint for modernizing PV; it is a bold move that tackles inefficiencies and reshapes case management to prioritize patient safety and operational excellence.

The impact of this collaboration extends beyond Sanofi. The innovations developed through ARTEMIS set a precedent for the broader life sciences industry, showcasing how automation and AI can drive meaningful progress.

As AI and automation play a larger role, the joint vision of the two organizations reminds us that innovation involves more than just using new tools: it's about envisioning better possibilities for outcomes. Together, Sanofi and IQVIA are establishing a new benchmark for the future of life sciences, not just shaping it.