When it comes to the electronic submission of safety data using the E2B format, meeting the often complicated and complex requirements of different regulatory agencies—EMA, MHLW, FDA and other NCAs—can be a challenge that consumes vast amounts of time and resource.
Across the globe, more than 55 customers, including major regulatory agencies, rely on agXchange ESM for electronically exchanging safety data such as ICSRs, SUSARs, attachments, and periodic reports. Aris Global® is the recognized leader in the implementation of the E2B standard for electronic communication of safety case data.
As part of the agXchange modular gateway for extended electronic exchange, allows organizations to quickly, easily, and securely transmit and receive electronic safety reports (E2B) to regulatory authorities and business partners across the globe.
As with all Aris Global products, agXchange ESM is available as a hosted solution on the
agOnDemand platform. For more than four years, agOnDemand has been providing best-in-class, cloud-based services to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.
The agXchange ESM solution 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.
Flexible mapping and configuration functionality 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. Other key features include:
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.