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Proprietary Safety Data

Limitless Data Options.

Evidex seamlessly normalizes, integrates, and maps any drug safety dataset - FDA Adverse Event Reporting System (FAERS), VigiBase, EudraVigilance, internal ICSR databases, and more. 

What's Included

Database agnostic functionality to extract case data from your internal safety database to Evidex for the purpose of signal detection, case review, and reporting on the ICSR database.

Industry's new gold-standard for cleaned, de-duplicated, and dynamically linked FAERS data. 

  • Machine learning algorithms combined with highly trained data analysts ensure 100% accuracy with speedy data updates
  • Best-in-class user interface, custom analytic and search capabilities
  • Dynamically mapped to MedDRA, ICD-10, RXNORM, and OHDSI CDM
  • Fully linked to other spontaneous reporting databases (VigiBase), Claims, and Social data for cross-data set comparisons
  • New FAERS data available in Evidex 5-7 days after made available by FDA

First of its kind safety focused clinical trial outcomes database, only available in Evidex.

  • Safety outcomes and adverse events from 17,000+ trials
  • Sourced from literature reviews and clinical trial registries such as ClinicalTrials.gov
  • On-demand pooled meta-analysis based on user defined criteria
  • Fully linked to other databases for cross-data set comparisons

Individual case safety reports from 100 countries, accounting for 90% of the world's population.

  • Fully mapped to all existing Evidex data for early signal detection and hypothesis generation
  • 15 Million reports of suspected adverse events going back to 1968
  • Global perspective on new and emerging safety issues
  • Developed and maintained by the Uppsala Monitoring Centre in Sweden in partnership with the World Health Organization (WHO)

The EMA requires marketing authorization holders to monitor safety relavent observations from EudraVigilance through eRMR line listing downloads from the EVDAS platform. Evidex allows for the automated import of those line listings into a Surveillance module to empower fast and audit ready adjudication. 

What makes our data, analytics, and software better?

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Built on Web 2.0 technology

Evidex is cloud-native, software-as-a-service built on next generation technology with a best-in-class user interface minimizing resources needed for implementation and providing tools safety reviewers want to use.

 

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Best-in-class customer support

Your Evidex Product Specialist is always available to train new users, conduct refresher sessions, or answer questions on-demand. In-app chat support is available in Evidex as is an interactive, online user guide. 

 

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Off-the-shelf, validated data integrations

Signal detection and advanced analytics on FDA Adverse Event Reporting System (FAERS), WHO's VigiBase, and our proprietary clinical safety database are included from Day 1.  

 

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Ready to take the next step? 

Integrated Signal Management

Audit-proof your process by tracking safety issues from clinical trials as post-approval.

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Advanced Data Analytics

Uncover hidden patterns, unknown correlations, and trends to become a value-added partner to your organization

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