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FDA Guidance For ABPM: Capture the Data That Matters

In May of 2018, the FDA issued draft guidance advising sponsors on assessing a drug’s effect on blood pressure during a clinical trial. Clarified further in 2019, this guidance is the result of regulators looking for a connection between blood pressure and cardiovascular events during drug therapy. To learn more about this FDA guidance, ABPM, and blood pressure monitoring best practices, please join us on July 18.

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Best Practices for Interpreting and Implementing FDA Guidance for Clinical Trial Imaging Process Standards

In the spring of 2018, the FDA issued updated guidance for its Clinical Trial Imaging Endpoint Process Standards. The FDA guidance focuses on imaging acquisition, display, archiving, and interpretation and recommends imaging endpoint process standards that are specific to clinical trials. Join ERT and Dr. Ford to discuss best practices to help you interpret and implement this FDA Guidance in your imaging clinical studies.

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How to Position Oscillometry in Respiratory Clinical Research

In this webinar Dr. Brian Lipworth, Head of the Scottish Centre for Respiratory Research, will discuss, Oscillometry methods and a comparison of impulse vs airwave oscillometry (IOS vs. AOS); How oscillometry is conducted, what is measured, and what this means for patients in clinical research; Trade-offs between oscillometry and spirometry Potential application of FOT/AOS in particular indications,

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Paper vs Electronic Clinical Outcome Assessments

Join ERT and Helen Lundblad, PRO Manager from AstraZeneca, to explore paper vs. electronic collection. Electronic collection of clinical trial data has been recommended by the FDA since 2009 . While error-prone paper diaries introduce unnecessary risks into your study, using electronic Clinical Outcome Assessments (eCOA) has been shown to better engage patients, improve data quality and accelerate trials.

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Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium

Regulatory authorities encourage sponsors to use ePRO systems and to provide site staff and study participant training on its use during clinical trials. Moderated and presented by ERT scientists Susan Dallabrida, PhD and Jenny Ly, PhD, the goal of this webinar is to promote consistent and sufficient training prior to initiating data collection.

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