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

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:

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.