Sanofi

Sanofi processes over 700,000 adverse event versions annually, with case volume growing up to 20% per year. Manual data entry across outsourced service providers resulted in inconsistent quality, inefficiencies, and rising costs. The company lacked the ability to prioritize high-complexity cases (e.g., clinical trial drugs) over low-complexity ones, stretching medical staff thin across all case types.

Sanofi launched Project ARTEMIS in 2019, partnering with IQVIA in 2023 to implement the IQVIA Vigilance Platform (IVP). The platform covers the full pharmacovigilance lifecycle—Collect, Intake, Case, Periodics, Analytics, and Signal modules—automating data extraction from source documents and populating safety databases automatically. The first phase (completed August 2024) deployed Collect, Intake, and Analytics with integration into existing safety systems, with a roadmap to replace the entire PV system with IVP by end of 2025.

Sanofi achieved a 15% reduction in pharmacovigilance operating costs compared to pre-automation baselines. The company targets 50% cost savings by 2027. The initiative also enabled a strategic shift toward AI-augmented medical evaluation, freeing expert staff to focus on complex, high-value cases rather than routine data entry.

• Automating intake and data entry is table stakes; the real differentiation comes from applying AI to complex medical evaluation tasks that most pharma companies haven't yet tackled.
• A long-term vendor partnership with co-development feedback loops (Sanofi → IQVIA → platform improvements) accelerates ROI beyond what off-the-shelf tools deliver.
• Reframing "a case is a case" to tiered case prioritization allows medical resources to be deployed where they have the highest impact, improving safety signal quality.