Major release containing enhancements to the Evidex Home Page displaying Evidex Alerts, Custom MedDRA Query Builder, and Evidex Signal Management.

The most recent Evidex Alerts are now displayed on the Evidex Home Page. Evidex Alerts are safety related news items generated by Advera’s analyst team which are emailed to users. These Alerts cover FDA safety labeling changes and new safety issues from quarterly FAERS reports, paired with actionable insight provided by our team of analysts.

Evidex Alerts can also be found on the "Alerts" tab for any Drug, Indication, MoA, or Drug Class page.

Read more about Evidex Alerts from our Help Center here.

To enable users to track their Product-Specific Monitored Events (PSME) within Evidex Signal Management, Advera added the ability for users to upload their PSME list within the CMQ Builder. There is now an 'Is PSME CMQ?' drop-down at the top of the CMQ Builder form.

Setting this to "Yes" will flag all Preferred Term adverse events within the CMQ as PSME terms within the user's ICSR database in Evidex Signal Management.

Surveillance
The 'Safety Relevant Observations' tab has been updated to "Surveillance - FAERS". We've also added the Chi Squared statistic to this page. Users can now filter their drug-event combinations by this statistic within the custom signal algorithm.
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Actions Entry Form

The actions data entry form has been rearranged to be more intuitive and user-friendly.