Global CRO selects PV Signal, PV Reports, and PV Analytics for signal detection reporting and analytics for a COVID vaccine company. The CRO which is focused on providing services primarily for Pharmacovigilance and Medical Information to pharmaceutical and medical device companies, recently acquired the contract to conduct safety services for a biotechnology company’s COVID vaccine. They are expecting approximately 400,000 to 500,000 adverse events a year.
The CRO had a number of homegrown tools and manual processes for signaling and reporting and wish to provide a more structured and automated process for tracking and reporting signals. In addition, they will look to utilize out-of-the-box algorithms such as Disproportionality Analysis, analysis of public databases such as EVDAS, VAERS, plus generating a Monthly Summary Safety Reports (MSSRs). The CRO will deploy PV Signal, PV Reports, and PV Analytics in the RxLogix AWS cloud.