Outbound submission tracking of adverse event information

Today the number of parties involved in the development & marketing of a drug, device or therapeutic agent has increased significantly and there is greater focus on safety regulations which have stringent submission requirements. Delays in internal communication between the various parties due to disparate time zones, or unclear information can lead to incomplete regulatory submissions or late delivery of a required report.

For most companies, local reporting remains the responsibility of the local safety office within each affiliate.

agXchange OST is the proven solution that 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 correct format for each of the local recipients.

As with all Aris Global products, agXchange OST

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.

Securely and efficiently support affiliate compliance

Using agXchange OST, 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.

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.

Organizations can send the affiliates only those safety reports that apply to them and with a simple, user-friendly interface (shared with agXchange IRT), the affiliate safety officer can add / review case data reports, make a reporting decision, enter any comments/reasons, and attach local cover letters or any supplementary data/documents that are required for the submission. Other key features include:

Outbound submission tracking of adverse event information

agXchange OST enhances the efficiency related to regulatory and partner submission of accurate safety case information on time. Other key benefits include: