ERT's Acquisition of PHT

Description

Applied Clinical Trials, February 2015 - This article discusses ERT's announcement of intention to acquire PHT. The combination of the companies creates innovative solutions for the rapidly-growing eCOA space.

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Incorporating Patient Reported Outcomes in Periodontal Clinical Trials By McGuire, M., Scheyer, T., Gwaltney, C.

Description

This commentary includes a review of split-mouth, randomized, controlled clinical trial results that specifically tracked pain at different sites over time after intervention and provided guidelines for peak pain time points and evidence for referred pain assessment when studying soft tissue augmentation procedures. Both the questions that are asked of patients and the timing of those questions are important study design considerations. The authors suggest PRO methodology for periodontal clinical trials that can be used to identify information important to patients and clinicians.

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Digital Patient: Disrupting the Status Quo - Contributions by Dr. Jeffrey Litwin

Description

PharmaVoice, September 2014 - The increase in the number of patients using digital technologies to improve their care is forcing the industry to create new strategies that include taking advantage of the large volume of patient data available but also utilizing digital tools to enhance patient engagement. In this article, Dr. Jeffrey Litwin of ERT provides his commentary on how scientific and technological advances have affected the way biopharmaceutical researchers collect patient centered outcomes data; including the bring your own device (BYOD) approach to eCOA data collection, as well as remote patient monitoring in clinical trials.

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Innovations in Assessing Cardiac Proarrhythmia Risk: New Strategy may Improve Cardiac Safety while Preserving the Drug Development Pipeline - By Dr. Robert Kleiman

Description

Applied Clinical Trials, July 2014 - This article discusses the requirement for the collection of cardiac safety data, concerns with current strategies, and a close look at recent innovations such as quantitative T-wave morphology analysis (QTWMA). The role of QTWMA in clinical studies and current regulatory positioning are also reviewed.

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What to Consider with a BYOD Approach to PRO Data Collection - by Chad Gwaltney

Description

Life Science Leader, May 2014 - In this article, ERT's Chief Scientist and Regulatory Advisor, Dr. Chad Gwaltney reviews the benefits and key trial design considerations sponsors should keep in mind when implementing a Bring Your Own Device (BYOD) approach to ePRO data collection in clinical research.

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