Deloitte and Sanofi automate pharmacovigilance case processing

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NEW YORK — Deloitte and Sanofi have collaborated on a next-generation, artificial intelligence (AI) software-as-a-service adverse events case intake platform called ConvergeHEALTH Safety to transform pharmacovigilance (PV) and address some of the industry’s biggest operational safety challenges. As an outcome of the initial deployment, Sanofi has already improved case quality and improved case processing efficiencies within PV by automating the case intake process, allowing Sanofi to focus resources on the rest of the adverse event (AE) case process and also on optimizing the benefit-risk profiles of their medicines.

Deloitte and Sanofi have been working for two-plus years to design, develop and implement a comprehensive solution and approach that combines Deloitte’s ConvergeHEALTH Safety Platform with knowledge from Sanofi and Deloitte.

“Reporting patient adverse events related to products or services is a critical component of Sanofi’s commitment to patient safety as well as a highly regulated process with stringent compliance policies,” said Stephen Kuske, Sanofi’s global head of Pharmacovigilance Operations. “For many companies, including Sanofi, the process also involves a significant manual workload to capture, enter and report safety information to various regulatory agencies globally. By working with Deloitte, we’ve been able to, for the first time, optimize quality and efficiency simultaneously.”

The new intake platform can help deliver results such as:

  • Improved case quality versus traditional manual data entry.
  • Significantly reduced end-to-end case processing times via simplified processing and quality improvements during case intake and data entry.
  • Continuous improvements of data science model efficiencies with the help of active monitoring.

“This collaborative initiative is a shining example of using advanced technologies in a highly-regulated area that not only leads with innovation and accelerates quality/efficiencies but allows pharmacovigilance to focus on what’s most important — the safety of our patients,” said Anand Ramanathan, Sanofi’s head of Digital Pharmacovigilance.

“Because PV is highly regulated, Deloitte and Sanofi implemented a risk-based, phased approach to make the solution for Sanofi a reality,” said Glenn Carroll, Deloitte safety leader and principal, Deloitte Consulting. “Our team recognized that technology alone would not solve the broader challenge facing Sanofi. Instead, we worked with Sanofi to understand their business, develop and implement a holistic solution, combining the data science and advanced analytics with our broad consulting experience, to help Sanofi transform their business and future-proof their patient safety reporting for years to come.”

Developed in collaboration with industry specialists as well as Deloitte alliances like Amazon Web Services, Deloitte’s ConvergeHEALTH Safety Platform includes: cognitive case processing; aggregate and operational reporting; signal detection, evaluation and management; and safety metrics, which can result in the following benefits:

  • Automated intake and processing to help significantly improve the efficiency and quality of the AE lifecycle.
  • Case-processing activities shift from manual data entry and coding to value-added review and analysis.
  • Faster, more efficient case processing, and with greater consistency regardless of source.
  • Reduced total cost of ownership and enhanced compliance.

Visit ConvergeHEALTH Safety for more information.


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