Steven Beales

An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in the pharmaceutical industry. He joined WCG ePharmaSolutions in 2009 and led implementation of the company’s Clinical Trial Portal at Genentech across 100+ countries. In 2015, he led implementation of the Clinical Trial Safety Portal at a top 5 pharma organization, which included a data-driven rules engine configured with safety regulations from those countries, which saved this organization hundreds of millions of dollars. Over 50 million safety alerts have been distributed by these two portals via the cloud. Prior to joining WCG ePharmaSolutions, Mr. Beales was the Chief Software Architect at mdlogix, where he led the implementation of the CTMS systems for Johns Hopkins University, Washington University at St. Louis, the University of Pittsburgh, and the Interactive Autism Network for Autism Speaks.

  • The Challenge of Overreporting: A Fresh Perspective from the FDA

    The Challenge of Overreporting: A Fresh Perspective from the FDA

    In a recent webinar, Steven Beales, Senior VP, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, discussing overreporting SUSARs and the impact on patient safety.

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  • New Normal or Not, Safety Reporting Matters

    New Normal or Not, Safety Reporting Matters

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  • Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

    Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

    Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

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  • Optimizing SUSAR distribution in a connected– but unharmonized–world

    Optimizing SUSAR distribution in a connected– but unharmonized–world

    Steven Beales and Joe O’Rourke, vice president, business development talk through some of the difficulties Sponsors face when it comes to safety letter distribution, and how to overcome them.

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  • Adverse Event Reporting: When TMI is Risky

    Adverse Event Reporting: When TMI is Risky

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  • How Roche Optimized its Global Safety Reporting Process for Clinical Trials

    How Roche Optimized its Global Safety Reporting Process for Clinical Trials

    Roche recognized several major challenges that its CTSP 2.0 system needed to address.

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