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ERT Demonstrates Patient Safety Expertise in Clinical Trials with New Knowledge Series of Papers
Date:1/14/2010

ars. ERT's ePRO solutions enable clients to capture sensitive findings directly from their patients, a process that is critical to proving the efficacy of their compound and its effects on patient safety. ERT offers a quick and easy, phone-based, voice-response solution, which is designed and optimized to help its clients collect clinically valid and sensitive data directly from participating patients. 

John Blakeley, Executive Vice President of ERT, comments, "We are pleased to be able to offer these informative papers to the scientific community as part of the new ERT Knowledge Series. We intend to expand upon these in the future, adding more innovative papers to the series on hot industry topics and sharing our expert knowledge on products and services for clinical trials."  

Jeffrey Litwin's paper on ECG centralization examines how central core laboratories are playing an increasingly important role in cardiac safety during clinical trials. In recent years, cardiac safety concerns have been cited as the most frequent reason for many new drugs and compounds being withdrawn from the market or receiving a refusal of regulatory approval. This paper demonstrates the importance of rigorous and accurate ECG data collection and analysis during clinical trials, discussing the benefits of a centralized approach to ECG collection.      

A second paper, entitled, "Is Centralization the Future for Cardiac Safety in Clinical Trials?", authored by Amy Furlong, looks at the importance of accurate and reliable ECG data collection and analysis. This paper expands on Jeffrey Litwin's paper to look at the future of cardiac safety in clinical trials. It covers the difficulty of estimating the true costs of cardiac safety, arguing the improved accuracy of digitally generated ECG data makes th
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