An issue within many drug safety departments is the accurate coding of cases based on the chosen dictionary for the company. Many times there is an exact match for the event, but other times there isn't and the case needs to be submitted for accurate coding, requiring the case to be removed from the managed workflow of Argus Safety™. And when a new version of the dictionary gets loaded, all cases need to be updated. Handling these processes manually can result in errors.

To rectify these issues and others, Relsys has developed an interface to TMS/dsNavigator to support centralized, real-time coding of events, patient history, cause of death, indications, and WHO products. It also allows for bulk updates to all Argus Safety™ cases when a new dictionary such as MedDRA is loaded into the system. And the interface is 21 CFR 11 compliant, of course.

• Reduce errors and improve department productivity
• Central coding across safety and clinical systems
• Real-time coding via an API call
• Omission Handling
• Bulk updates of Argus Safety™ cases upon loading of a new dictionary