Aris Global Software Pvt. Ltd.

agXchange IRT

Inbound receipt & triage of adverse event information

Do you worry about the repercussions you may face due to possible incomplete regulatory submissions or even late delivery of a required report? For any life science company, the reporting clock starts once any member of a life science organization becomes aware of a safety event.

agXchange IRT enables organizations to securely and efficiently receive adverse event information from diverse constituencies: affiliates, co-development partners, consumers, healthcare providers, CROs, and headquarters' staff. As a result,

Using agXchange IRT , companies can avoid delays in internal communication—due to disparate time zones or unclear information, for example—which can lead to incomplete regulatory submissions or even late delivery of a required report.

As with all Aris Global products, agXchange IRT is available as a hosted solution on the agOnDemand platform. For more than four years, agOnDemand has been providing

Pharma_agXchange_IRT

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 receive adverse event information from affiliates

Using agXchange IRT, staff at headquarters has the opportunity to review and assess the information sent by affiliates prior to accepting the information into ARISg and checks against existing cases in the safety database to ensure that duplicate case information is not entered. During this assessment phase, organizations can assess whether information received should go through the extensive safety-review workflow. Information assessed for follow-up action can be forwarded to designated individuals when appropriate. agXchange IRT offers these other key features:

  • Receives cases in any format from any source
  • Triages and assesses received items
  • Enables online case entry (for affiliates)
  • Provides split-screen review
  • Identifies duplicates, new cases and new versions
  • Follow-up with reporter

Maintain compliance and reporting requirements while controlling costs

agXchange IRT takes advantage of the inherent productivity benefits of electronic communication, serving to decrease the amount of time organizations spend collecting and verifying safety information and increase their ability to report complete and accurate safety case information on time. Other key agXchange IRT benefits include:

  • Enables timely and accurate receipt of safety information
  • Supports multiple formats, including email with attachments, fax and E2B
  • Provides flexibility to create custom data-entry forms
  • Contains a built-in document management system (DMS), supporting versioning, storage, checkout/checkin, and configurable watermarking
  • Facilitates duplicate case checking
  • Supports triage of AE information from a centralized location prior to full case processing
  • Tracks internal and external communications
  • Reduces processing and administrative costs for affiliates
  • Improves inspection readiness through demonstrated local tracking system from receipt (IRT) to submission (OST)