The Problem

Sanofi Genzyme’s registries are industry models in both design and execution of long-term observational studies. They play a critical role in advancing the global understanding of disease, analyzing treatment outcomes over time, and fulfilling regulatory requirements related to life-threatening genetic diseases.

The Benefits

RegistryNXT!, implemented using the N of 1 Health Research Platform, is an innovative solution that includes:

  • Fully integrated portal providing single sign-on access to data collection tools and analytical graphs and reports.
  • Integration with Medidata’s RAVE, the leading clinical trial data collection application.
  • Real-time data interchange using CDISC standards.
  • Role-based disease management for patients, physicians, and nurses.
  • Reporting functionalities for sites, registry staff, and Sanofi Genzyme regulatory reports.
  • A production system based on the CDISC BRIDG model for health care and clinical trial data.