CaseIRT is a simplified multi-channel adverse event case intake, receipt and triaging solution with advanced automation capabilities to facilitate fast and intelligent case processing
Multi-channel Case Intake
Streamline incoming cases from different channels
With a robust multi-channel case intake capability of CaseIRT, all inbound cases can be seamlessly collected from various channels including web, email, clinical trial portals, mobile app, etc. using readily available channel adapters. Cases from social media, literature and HCPs can also be redirected to CaseIRT for receipt and triage.
Intake Automation – AI & Native Functionality
Automate case processing of non-serious adverse events
Leverage CaseIRT’s automation capabilities through Artificial Intelligence using techniques like NLP and Machine Learning to automatically parse raw source data and create a structured AE case from standard form such as CIOMS or from any non-standard case form. In addition, CaseIRT also has native workflow driven functionalities which trigger various downstream case processing tasks.
Having difficulty in tracking all inbound cases?
As part of case receipt, CaseIRT provides both automated and user action driven workflows to populate case queues for triaging and has configurable channel specific receipt acknowledgements. The audit trail keeps a record of all actions taken resulting in better regulatory compliance.
Case Transmission and Triage
Significantly reduce case processing times
The triage functionality in CaseIRT is built on the E2B R3 and R2 regulatory standards. Using version controlled automated transmissions, all received AE cases can be triaged in CaseIRT and immediately sent to downstream safety databases such as Argus Safety and Aris Global’s Lifesphere Safety application without any manual data entry.
CaseIRT Email Inbox
Establish unified case communication
Using the built-in CaseIRT email Inbox, all incoming adverse event cases from multiple stakeholders and non-voice sources can be centrally managed without having to use any other external email system. A case can be created directly from inbox with the source attachments after which receipt and triage workflows can be triggered.
Process Alerts & Notifications
Take risk-based proactive decisions
Keep a track of all inbound case status and avoid delays in adverse events case processing with CaseIRT’s automatic process alerts and notifications. Reduce process deviations, quality deficiencies and eliminate compliance shortfall with immediate time-bound email alerts.
Cross Functional System Integrations
Get triaged cases transmitted instantly to downstream systems
With CaseIRT’s readily available integration capability with your existing Drug Safety and Product Quality Complaint Management Systems, leverage the E2B enhanced case transmission capability to seamlessly send all triaged cases for further action.
Business Intelligence Studio
Define. Measure. Evaluate. Transform
The standard reports in CaseIRT will facilitate end users to generate data listings using dynamic data filters to track each stage of case life cycle such as intake, receipt and triage. Gain operational insights using interactive visual KPI dashboards and track product specific case processing metrics.