Aris Global Software Pvt. Ltd.

agXchange SIR

Securely and automatically distribute safety-to-investigator reporting

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


Investigator portal facilitates easy access to all safety information

agXchange SIR takes advantage of the inherent productivity of electronic communications, reducing the amount of time organizations spend manually distributing and tracking receipt of safety information. Investigators log on to a user-friendly portal and select their preferred method of receipt, fax, email or portal. After a report has been viewed, automatic acknowledgements are sent to the SIR portal enabling sponsors to quickly and accurately track receipt and generate detailed transaction history reports.

With agXchange SIR , sponsors can automatically distribute clinical safety reports such as SUSARS and aggregate line listings to investigators and other stakeholders based on a defined distribution list. Optional link to CTMS

Clinical AgExchange SIR

investigator database address books or other safety databases, including ARISg , further extends the rich functionality that agXchange SIR delivers. Delivered as a hosted /managed solution, agXchange SIR eliminates the need to invest in new hardware, software, or staff and 24x7 help desk support is provided by Aris Global.

As with all Aris Global products, agXchange SIR 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.

Easy access to all safety information

The web-based trial report distribution system leverages Aris Global’s 20-plus years of clinical safety experience and is the first such system to be designed specifically for the investigator.

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. Other key features include:

  • Information is distributed via investigator portal, email or fax
  • Hosted model eliminates the need to invest in new hardware, software or staff
  • Capable of linking to CTMS databases
  • Operates stand-alone or linked to any clinical safety system
  • Quick ROI by eliminating mailing and distribution costs

Reducing the cost of clinical safety report distribution

The increasing cost of collecting, distributing and tracking safety reports and other outbound trial documents to investigators, represents a significant burden for many sponsors. Using agXchange SIR , companies can eliminate the entire manual and labor-intensive process required to print, sort and send the increasing volume of safety information impacts staff productivity; time that can be better spent on core business activities.

  • Automates and accelerates safety-to-investigator report distribution
  • Improves/ensures compliance with international reporting regulations
  • Provides central view of report distribution
  • Reduces follow-up activity using automated acknowledgements
  • Delivered as a hosted solution, agXchange SIR eliminates the investment in new hardware, software, and new application and infrastructure support staff