Improving Your Drug’s Value Proposition throughout the Product Lifecycle: How Optimized Clinical Outcomes Assessment (COA) Strategies Can Drive Commercialization Success

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Typically, pharmaceutical and biotech companies have focused their Clinical Outcome Assessment (COA) development efforts solely on the requirements necessary for regulatory approval.  While we recognize that is extremely important, today we are going to discuss how pharmaceutical companies may reap …

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Metrics Champion Consortium – Cardiopulmonary Performance Metrics Initiative

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ERT Blog with guest, Linda Sullivan – Vice President Operations, MCC The Metrics Champion Consortium (MCC) is a non-profit organization comprised of approximately 90 biotechnology, pharmaceutical, medical device and service provider organizations.  Their mission is to help sponsor and service providers …

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The Importance of Inspiratory Capacity in COPD Clinical Trials

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Written by: Dawn Patterson, Supervisor Respiratory OverRead On average, it costs $539 per person annually to treat an asthmatic and $4,150 to treat COPD.  These costs reveal a need for improved symptom management and reduction in exacerbations that would reduce the need …

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CLEAR Study Update: A look inside the collaboration between ERT and UCLA

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Written by: Michael Taylor – Senior Director, Healthcare Solutions As some of you may remember, back in February 2012, ERT collaborated with the University of California, Los Angeles (UCLA) to launch the CLEAR study, an innovative research study aimed at …

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Brief Report – Changes to the FDA Draft Guidance Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials

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The original Draft Guidance was released September 8, 2010 Prospective assessment of  suicidality Identify patients at risk Collect complete, timely data Perform in every phase, in every trial, at every visit In all psychiatric indications In all neurology compounds For …

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