Leading Irish CRO ICON has introduced a new global safety reporting system. This product space has long been dominated by a couple of vendors and is ripe for disruption. Argus Safety (Oracle) maintains the largest market position and Aris G is second.  

Now with ICON’s new market entry the product is built on business process management platform Pega 7.  ICON positions that it infuses regulatory intelligence from 80 countries.   With date-stamped decision rules it will facilitate the required distribution of safety reporting worldwide.   The CRO purports that advanced levels of automation will differentiate this product from the existing packages on the market. ICON positions that this new reporting system can be deployed by itself or interfaced with legacy systems.  The system was developed by an internal group known as the ICON Automation and Centre of Excellence.

TrialSite News doesn’t advocate any one system over another.  We do champion the cause of technological progress in the drug development ecosystem.  A key challenge is the gap between executive leadership vision, managerial strategy and operations’ execution.  Any new technological breakthrough in the clinical operations space requires process change. This is difficult to do. Imagine, a large pharmaceutical company with over 50 country affiliates—each one may have their own nuance and approach for conducting business. But in the case where there are compliance drivers that process alignment should be easier. We always recommend piloting a system, but even before you do that—understand your requirements. In the FDA/EMA regulated space you must validated your systems which means you will need a document user requirement specification (URS) for validation.  Make sure you structure contracts that the vendor is on the hook to help support that process.

Source: AP News

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