Key Features/Benefits

Transmit and receive ICSRs, SUSARs, attachments, and periodic reports

Electronic exchange of safety documents with regulatory authorities and partners

Fully integrated with ARISg / ARISj – no separate menu or installation

Allows exchange of ICH E2B(R2), ICH E2B(R3), and eMDR v1 formats

Provides options to place incoming electronic messages directly into ARISg/ARISj or into agXchange IRT for triage alongside other inbound safety reports

Background

The FDA, EMA and MHLW have either mandated or actively encouraged electronic safety report submissions using the E2B R2 format.  However, the complex and numerous requirements of different regulatory agencies combined with local legislation has meant that even “standard” formats need to be tailored for different jurisdictions.  Further, many life sciences companies have different data collection and operating standards and often work with partners who may have specific and complicated exchange agreements.  Ensuring that each agency or partner receives just the right format on a consistent basis is a difficult challenge that can take up a huge amount of resource and time.

agXchange ESM – Electronic Safety Submissions

agXchange™ ESM is an electronic safety message exchange system that supports the submission and receipt of ICSRs between regulatory agencies and commercial partners, tracking MDNs and acknowledgements.  Standard and derivative versions of ICH E2B and eMDR message formats can be transmitted and received to meet the needs of each recipient and sender.  To facilitate local authority mandates including the Japanese J-items and local partner requirements, agXchange ESM provides a flexible mapping and configuration capability that allows custom and extended E2B formats to be defined.

agXchange ESM is fully integrated into ARISg / ARISj, but is also database independent and can be used to provide electronic safety messaging capabilities to any safety system.  Backlog ICSRs, periodic ICSRs, spontaneous ICSRs, and attachments can all be distributed to allow a full transition from paper to electronic reporting, and ongoing compliance with both post-marketing and periodic reporting obligations.