PVSentinel IRT enables Pharma companies to simplify multi-channel adverse event case intake, receipt, and triaging. The advanced automation capabilities facilitate fast and intelligent case intake from various channels in different data formats. It also has a built-in Inbox for distribution of emails on safety mailbox to different business partners and vendors.
With a robust multi-channel case intake capability, collect all inbound cases from various channels including web, email, clinical trial portals, mobile app, etc. Cases from social media, literature and HCPs can also be redirected for receipt and triage.
Leverage ready to be deployed automation capabilities through OCR and Artificial Intelligence using NLP/ ML techniques to automatically parse raw source data and create a structured AE case from standard form such as CIOMS or and nonstandard AE Report/Snapshot.
Using the built-in email Inbox, all incoming adverse event cases from multiple stakeholders and 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.
Keep a track of all inbound case status and avoid delays in adverse events case processing with automatic process alerts and notifications. Reduce process deviations, quality deficiencies and eliminate compliance shortfall with immediate time-bound email alerts.
All received AEs and their versions can be triaged automatically to downstream drug safety systems using industry data standards such as E2B R2/R3 formats. Industries most used safety databases such as Oracle Argus Safety, Aris Global Lifesphere are seamlessly supported with our Bi-Directional integration.
PVSentinel IRT is available on iOS and Android devices with support of data capture on configurable forms. Solution can also be deployed as a web portal for submission of Adverse Events for intake, review and further processing.
Get insights into operational and intake data with our built-in reporting and analytics module. Our Solution comes with 40 + standard reports and dashboards.
PVSentinel IRT adheres to global compliance such as GxP, HIPAA and EU-GDPR regulations with the setup of country specific data privacy rules. Organization can conduct business operations as per applicable data protection company policies.
PVSentinel IRT is a 21 CFR Part 11 and Annex 11 Compliant solution with a non-editable audit trail and transaction history for all the activities performed in the system.
PVSentinel IRT with Mailbox is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform such as Case Exchange & Reconciliation, L2A Filter etc.