agXchange OST™

outbound submission tracking of adverse events

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 support affiliate compliance

As part of the agXchange™ modular gateway for extended electronic exchange, the agXchange OST module allows organizations to more closely integrate their affiliate offices into the processes of collecting and submitting safety information while gaining a centralized overview of all global safety activity. Ready-to-submit case reports are delivered electronically to the affiliates' inbox, in the right format for each of the proposed set of local recipients.

Ready-for-reporting case list

Upon completion of processing in the safety system, cases are automatically routed to agXchange OST for final review, reporting decision and submission by the local offices. The listing distinguishes between submissions to health authorities and to partners. For each submission, the report in the appropriate format is available together with the cover letter. The user may make the reporting decision at the case level or at the recipient level. This way, the local office can get an additional level of control over submission to only qualifying recipients based on local assessment.

Using agXchange OST, companies send the affiliates the safety reports that apply to them and with a simple, user-friendly interface (shared with agXchange IRT), the affiliate safety officer can add / review the case data/report, make a reporting decision, enter any comments/reasons, and attach local cover letters and supplementary data/documents required for the submission.