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Advera Health Analytics, Inc.

Real-Time Drug Safety Analysis with Evidex Alerts

Posted by Bob Kyle on Jan 20, 2017 10:30:00 AM

Nesina.pngThis week we launched Evidex Alerts, a new feature that provides our clients with real-time updates on the latest impactful drug safety news. This is a project that our development and analyst teams have worked on diligently for the last three months, and I am excited to announce that it became a reality this week. 

Our scope of coverage will be important safety-related events that most concern our clients who are making drug utilization decisions and monitoring drug safety & risk. Initially our analyst team will be covering four specific types of events:

  1. FDA Drug Safety Labeling Changes. This will alert clients when any new significant adverse event risk is added to a marketed drug’s label.  We analyze each of these newly labeled adverse events to determine whether Advera had an active RxSignal or disproportionate reporting for this risk prior to the Alert. We also provide insight on what the impact of this change will be.
  1. New Drug Approvals. This will alert clients about any drug approval that happens in the United States. It will also describe the overall safety profile of the newly approved drug, including any specific warnings on the drug’s label, and specific serious adverse events risks disclosed on drug’s label or reported in late-stage clinical trials. It will also compare that drug’s safety profile compared to other existing treatment options for that indication.
  1. FDA Regulatory Announcements. This will alert clients when any new significant regulatory announcement is made by the FDA which relates to safety, including new black box warnings, drug safety announcements, and drug withdrawals.
  1. Clinical Trial Safety Results. This will alert clients when a new piece of clinical trial data is released for either a marketed or developmental compound. The Alert will focus on the safety results, including Serious AE (adverse event) Rates, Total AE Rates, Discontinuation Rates, and Specific AE Rates of interest for the particular drug and any comparator or control drugs in study.

All this valuable insight is sent via email to clients based on their specific interests. Clients can set the timing of their Alerts (real-time, daily, or weekly), and they can set the parameters of their Alerts (based on Alert type, or a set of specific drugs or companies).

Over the last year, we have devoted our product development resources to adding a large amount of innovation to the Evidex platform, with the ultimate goal of making drug safety data more actionable.

We’ve added the Advera Clinical Evidence module which aggregates curated clinical trial safety data, putting FAERS safety datain context and providing a more accurate risk evaluation picture:

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We’ve created Drug/Adverse Event profiles which summarize all relevant safety information on a specific drug/AE risk (safety signals from FAERS, clinical trial data incidence rates, literature references, etc.) in one easy-to-review snapshot.

And we help users proactively understand a potential drug induced condition with the Adverse Event profile, which highlights a list of drugs which could be causing a certain safety issue:

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With this new launch, Evidex Alerts breathes life into our analytics by alerting clients anytime the safety conclusion or risk profile on a drug changes. 

In addition to keeping our clients informed, Evidex Alerts also draws a real-time measuring point to compare when the FDA or company sponsor acts on a specific safety issue and when our signaling analytics first warned on that safety issue.    

Lastly, Evidex Alerts showcase the value of integrating multiple sources of evidence into safety and risk management by highlighting in real-time important clinical safety results on both developmental and marketed drugs.  This helps our customers better evaluate both risk and value of that drug compared to the competitive landscape.

We believe the value of Evidex Alerts to be significant and as such are offering complimentary trial accounts to our qualified readers. Contact us for more information.

 

Bob Kyle, Chief Product Officer

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Topics: Drug Safety, Clinical Trials, Evidex

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