agXchange IRT™

inbound receipt and triage of adverse event information

Delays in internal communication—due to disparate time zones or unclear information, for example—can lead to incomplete regulatory submissions or even late delivery of a required report.

Securely and efficiently receive adverse event information from affiliates

As part of the agXchange™ modular gateway for extended electronic exchange, the agXchange IRT module enables organizations to securely and efficiently receive adverse event information from diverse constituencies: affiliates, co-development partners, consumers, healthcare providers, CROs, and headquarters' staff.

Inbound receipt and triage

agXchange IRT allows organizations to more closely integrate their affiliate offices into the process of collecting and submitting safety information. Users at off-site locations can electronically submit information in many different formats, including email with attachments, fax and E2B.

Staff at headquarters then has the opportunity to review and assess the information prior to accepting the information into ARISg™, the world's leading pharmacovigilance and safety system. The module checks against existing cases in the safety database to ensure that duplicate case information is not entered. During this assessment phase, organizations can assess whether information received should go through the extensive safety-review workflow. Information assessed for follow-up action can be forwarded to designated individuals when appropriate.

Maintain compliance and reporting requirements while controlling costs

agXchange IRT takes advantage of the inherent productivity benefits of electronic communication, serving to decrease the amount of time organizations spend collecting and verifying safety information and increase their ability to report complete and accurate safety case information on time.