Japan and China Integration

Master local ICSR reporting specifics with globally integrated solutions

Japan and China are two of the “frontrunner” countries for implementing and mandating the most recent E2B(R3) standard for ICSR reporting. These changes in regulatory requirements can also be utilized to improve the process and system integration in a global environment.

Process integration
+ Unification of data entry and medical assessment processes
+ Integration of local assessment capabilities

Safety system integration
+ Implementation of a fully integrated solution with one single global safety DB
+ Integration of legacy data and decommissioning of local legacy system

Reporting to health authority
+ Coverage of regional implementation guides and language specifics for PMDA (Japan) and CDE (China)
+ Support for selection of local service provider if required