agXchange™

eSafety ICSR Submissions Software

The electronic submission of safety data is a mandatory requirement in Europe and Japan. The FDA has initiated a voluntary reporting program, but it is actively encouraging the submission of adverse event reports electronically.

agXchange is Aris Global's industry-leading electronic submissions software with more than 50 installations supporting the submission of ICSRs and SUSARs to EMEA, MHLW, FDA and other NCAs. Integrated with the required encryption protocols AS2/AS1 etc., agXchange enables the secure exchange and management of safety data with global trading partners and the regulatory authorities. agXchange can easily be configured to meet authority specific requirements by allowing users to setup recipient specific content.

Authorized users can review ICSRs and SUSARs awaiting transmission and transmit cases individually or in batch. Successful load or load-error destination acknowledgements can be reviewed and imported back to the source safety system.

All incoming safety reports are displayed in agXchange prior to import into the live database. agXchange automatically parses the E2B file, identifying any errors in the imported data. Appropriate acknowledgements are transmitted in accordance with the E2B definitions. Error-free cases can then be imported directly into your pharmacovigilance system for further processing and analysis.