Sanofi Pasteur Reduces Vaccine Clinical Trial Times with Electronic Data Capture
 
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Sanofi Pasteur Reduces Vaccine Clinical Trial Times with Electronic Data Capture

  • Oracle Customer:  Sanofi Pasteur
    Location:  Lyon, France
    Industry:  Life Sciences
    Employees:  13,000
    Annual Revenue:  Over $5 Billion

Sanofi Pasteur, the vaccines division of the Sanofi group, is the first company in the world dedicated entirely to human vaccines. Its mission is to protect and improve human health by providing innovative vaccines at the very highest standards of quality, and to play an active role in supporting the players in the public health sector. At its 12 sites, Sanofi Pasteur researches, develops, and produces more than 1 billion doses of vaccines each year to vaccinate more than 500 million people worldwide.

 
 

 
 

Challenges

A word from Sanofi Pasteur

  • “Oracle Health Sciences InForm is a valuable communication tool for all those involved in vaccine clinical trials. It decompartmentalizes their work so they can share data in real time and interact to resolve health or ethical questions in a completely secure, traceable environment.”–Isabelle Vieux, Head of Clinical Trial Analysts, Sanofi Pasteur

  • Reduce paper use for data processing related to vaccine clinical trials and share results more quickly using an electronic data capture (EDC) system
  • Accelerate launches of vaccines for public health purposes
  • Simplify compliance with regulations, including requirements for clinical trial traceability and compiling new data for reporting

Solutions

Oracle Product and Services

  • Selected Oracle Health Sciences InForm to reduce paper use on clinical trials, so far converting approximately 60 trials involving nearly 60,000 patients
  • Replaced a multiple-step data capture process that involved the researcher and double data entry on paper, instead allowing one-off online capture of trial data by the researchers
  • Lowered average clinical trial times significantly, which helped bring vaccinations to the market more quickly
  • Reduced data capture times and risk of errors, while also simplifying data security, thanks to the reduction in paper-based processes
  • Gained several extra weeks to share clinical data with bio-statisticians, medical doctors, clinical research assistants, pharmacovigilance department, and others
  • Enabled real-time collaboration between all players involved in clinical trials—including researchers, pharmacovigilance and monitoring professionals—thanks to workflows that allow asking questions, making requests, sharing results analyses, and other activities
  • Centralized traceability regarding updates to clinical data
  • Implemented, hosted, and maintained solution internally
  • Improved ability to react swiftly in the event of epidemics by enabling the company to more quickly launch vaccines