EV Triage
Intelligent, automated triage of E2B cases from EVWEB.
JUMP TO
Automating the Triage of MAH-Applicable E2B (R3) Cases from EVWEB
As marketing authorization holders (MAHs) strive to meet the EMA requirement of downloading E2B (R3) files from the EVWEB portal, LifeSphere EV Triage is the cloud-based software tool that automates the triage process of segregating and reconciling applicable cases from other non-relevant cases.
BENEFITS
Accelerate Aggregation and Reconciliation
Reduce the manual effort required to separate the cases relevant to marketing authorization holders.
Collaborate Better
LifeSphere EV Triage offers full interoperability with any pharmacovigilance system and the E2B converter of choice.
Get Going Faster
LifeSphere EV Triage deploys quickly as a cloud-based plug-in as well as on-premise.
RESULTS
Delivering Real Results to a Global Client Base
80
%
Global Colaboration
80% of the top 50 pharma companies are our clients
80
%
Efficiency Gains
80% potential efficiency gains driven by our Nava cognitive computing engine
30
%
Cost Savings
30% immediate cost savings potential via our advanced automation capabilities
100
%
Compliance
100% compliance with all present and upcoming regulatory standards
FACT SHEET
Delivering Efficiency Through Intelligent, Automated Triage of E2B Cases from EVWEB
LifeSphere EV Triage is a cloud application that automates triage of applicable
EVWEB cases from non-relevant cases, bringing peace of mind and efficiency gains to busy safety teams.
WHITEPAPER
Automated Segregation of Relevant ICSRs from EudraVigilance
One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system.
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PARTNERS
Partnering With the Industry’s Best
FEATURES
Improve Efficiency, Productivity, and Cost Savings.
Easy Zip File Importing
LifeSphere EV Triage provides automated pooling of zip files from a folder, and the capability to upload zip files that have been downloaded from EVWEB.
Smart Analysis with Auto-Matching
LifeSphere EV Triage provides a direct match, fuzzy match, narrative analysis, matching against a local corpus, and corpus sync with the safety product library. It also provides a reconciliation report generation based on a date range or zip file name.
Intuitive User Interface
LifeSphere EV Triage offers date-wise segregation of processed zip files, summaries of each download zip file, matching attributes in a single listing, and easy visualization. It also offers matched attribute highlighting, easy views all products and narrative from XML, and easy data exchange with Microsoft Excel.
Out-of-the-Box Readiness
The only proven and validated off-the-shelf solution to offer one platform for all safety surveilance needs, resulting in a more efficient drug development process and cost reductions.
Worry-Free Implementation and Integration
Fast, professional implementation teams adhere to industry best practices to get your teams up and running quickly.
Connect with existing systems via API connectors and web services.
Best-in-Class Implementation Partner
ArisGlobal wants to help make your journey as effortless as possible – not just at the beginning, but over the long-term. A multitude of support and service options, including Managed Services, Professional Services,
and Lifeshere Training.