agXchange ESM™

E2B safety submissions module

When it comes to the electronic submission of safety data using the E2B format, meeting the often complicated and complex requirements from different regulatory agencies—EMEA, MHLW, FDA and other NCAs—can be a challenge that consumes vast amounts of time, effort and resources.

Aris Global^® is the recognized leader in the implementation of the E2B standard for electronic communication of safety case data. Across the globe, more than 55 customers, including major regulatory agencies, rely on agXchange ESM (formerly E2B Gateway™) for electronically exchanging safety data such as ICSRs, SUSARs, attachments, and periodic reports.

A proven solution for E2B safety submissions

As part of the agXchange™ modular gateway for extended electronic exchange, the agXchange ESM module allows organizations to quickly, easily, and securely transmit and receive electronic safety reports (E2B) to regulatory authorities and business partners on a global basis.

agXchange ESM manages and traces all electronic distribution of regulatory safety submissions and receipts in order to meet complex and often differing regulatory requirements. The application also supports the submission of differing content dependent on the receiver meting local reporting obligations.

Open integration and flexibility

agXchange ESM offers flexible mapping and configuration to allow for the electronic exchange of files in a custom format. While agXchange ESM is fully integrated with the ARISg safety system, it is database independent and can operate seamlessly with any safety system.