agXchange SIR™

safety-to-investigator reporting

The steep costs of collecting, distributing and tracking safety reports and other outbound trial documents to investigators represents a significant cost burden for many sponsors. The entire manual and labor-intensive process required by clinical staff to print, sort and send this increasing volume of safety information impacts productivity that could be better spent on core business activities. More seriously, if the traditional manual process lengthens the time it takes for valuable safety information to reach investigators potentially raising serious safety concerns.

Securely and automatically distribute safety reports to investigators

As part of the agXchange™ gateway for extended electronic exchange, the agXchange SIR module enables organizations to automate the distribution of clinical safety reports and other clinical documentation to investigators, central IRBs, ethics committees and other stakeholders.

The new Web-based trial report distribution system leverages Aris Global's 20-plus years of

clinical safety experience and delivers first-to-market capabilities that are designed from the investigator's perspective.

Hosted trial report distribution

Through agXchange SIR, Sponsors can automatically distribute clinical safety reports including SUSARS or aggregate line listings to investigators and other stakeholders based on a defined distribution list or to all studies associated with a product. The fully automated system significantly reduces the effort to collate, compile and distribute safety reports therefore reducing the associated costs. Optional links to a CTMS database's investigator address book and to any safety database, including ARISg™, further extend the rich functionality that agXchange SIR delivers.

Delivered as a hosted Software-as-a-Service solution, agXchange SIR eliminates the investment in new hardware, software, and new application and infrastructure support staff. Help desk support is provided by Aris Global, leveraging its long-standing leadership experience in safety and pharmacovigilance to deliver superior 24/7 assistance to your organization's investigator community.

Investigator portal facilitates easy access to all safety information

agXchange SIR takes advantage of the inherent productivity benefits of electronic communication, serving to decrease the amount of time organizations spend manually distributing and tracking the receipt of safety information.

Investigators log in to a user-friendly portal and select their preferred method of receipt-fax, email or portal. After a report has been viewed, automated acknowledgements sent to the SIR portal enable sponsors to quickly and accurately track receipt and generate detailed transaction history reports.