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Advera Health Analytics Launches COVID-19 Vaccine Safety Module on Evidex Platform
  • USA - English

Clinical and Real-World Vaccine Data and Analytics Now Available for Pharmacovigilance Signal Detection and Management


News provided by

Advera Health Analytics, Inc.

Jul 26, 2021, 08:00 ET

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SANTA ROSA, Calif., July 26, 2021 /PRNewswire-PRWeb/ -- Advera Health Analytics, a market leader in cloud-based software and data-as-a-service drug safety solutions, today announced that it has launched a comprehensive Vaccine Safety Signal Detection and Management module on its market-leading Evidex platform. The Vaccine Safety module includes safety risk signals that Advera curates, cleans, and de-duplicates from the Vaccine Adverse Events Reporting System (VAERS) compiled by FDA and CDC along with comprehensive clinical safety outcomes data that Advera curates from FDA's ClinialTrials.gov. Advera is already a market leader in providing optimized and curated drug safety data, advanced statistical analysis, critical workflow tools, and real-world research study support to the pharmaceutical industry. Today's announcement extends those capabilities to vaccine manufacturers worldwide and the companies that support them.

Evidex's new Vaccine Safety module database contains over 1.2 million unique adverse drug event reports, with over 450,000 reported so far in 2021 alone. In addition to the COVID-19 vaccines, the Vaccine Safety module in Evidex contains comprehensive clinical and real-world data on over 100 vaccines used daily to treat a wide variety of health issues, including influenza, tetanus, shingles, HPV, hepatitis, diphtheria, and smallpox. Using the advanced analytical capabilities now available out-of-the-box on Evidex, manufacturers and life science professionals will be able to quickly detect, analyze, validate, mitigate, and manage any safety signal that arises from these quickly emerging data. Data from the VAERS system will be updated weekly and data from the ClinicalTrials.gov system will be updated monthly. New data sources and additional functionality will be added as they become available.

For a limited time, qualified industry members can register for a free Evidex trial, including the new Vaccine Safety module at: https://info.adverahealth.com/free-trial-pr

"With worldwide attention on the currently available COVID-19 vaccines and with many more likely to become available through 2021 and 2022, we felt it was the right time to expand our market leading drug safety capabilities into the vaccine space", said Brian Overstreet, President and CEO of Advera Health. "The curated vaccine safety data, analytical tools, and management workflow capabilities that are we are providing to manufacturers will jump start the tracking and adjudication of safety issues as they emerge with these new vaccines and vaccine candidates. We are proud that this effort will ultimately contributing to greater patient safety and higher vaccination rates."

Robert F. Kyle, Chief Product Officer of Advera Health added, ""Understanding post-market safety data for the three currently authorized COVID-19 vaccines may be the greatest challenge the pharmacovigilance industry has ever faced. At Advera Health, we believe that applying our innovative Evidex signal detection and signal assessment tools to the Vaccine Safety module can enhance the overall understanding of the safety profile of these products.    With over 450,000 reported adverse event cases (as of July 9th, 2021) and nearly 160 million fully vaccinated patients in the United States so far (and nearly 1 billion globally), the Evidex Vaccine Safety module provides a much-needed solution for conducting real-world COVID-19 vaccine analyses and research studies."

About Advera Health Analytics
Advera Health Analytics is a global leader in pharmacovigilance software, analytics, and data at the leading edge of drug safety science. Advera Health has created Evidex, a next generation pharmacovigilance platform to connect disparate drug safety data sources and provide a user experience that elicits actionable intelligence from those data. The Evidex platform links to internal ICSR databases, FAERS, VigiBase, EVDAS, Claims/EHR, EDC and other data and provides for a validated, audit ready environment to track and manage safety issues that are found in those data. Founded by a group of passionate healthcare entrepreneurs, Advera Health's mission is to mitigate risk in the healthcare system by improving the transparency and actionability of drug safety data through the curation and aggregation of large disparate datasets and the application of advanced analytics and workflow. Please visit http://www.adverahealth.com for more information about the company.

Media Contact

Brian Overstreet, Advera Health Analytics, Inc., +1 707-387-9230 Ext: 500, [email protected]

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SOURCE Advera Health Analytics, Inc.

Related Links

http://www.adverahealth.com

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