Decentralized Trials

EU regulators expand use of remote source data verification in clinical trials

02/16/2021

Excerpt from the Article: The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials. Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few…

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Best Practices For Implementing Decentralized Clinical Trials

02/16/2021

Excerpt from the Article: Today’s new COVID realities mean changes in how clinical trials are administered. Here’s what to consider in adopting decentralized clinical trials. As the COVID-19 pandemic turned the world upside down, clinical trials have been deeply impacted, with thousands of trials either canceled or delayed — all during a time in which…

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Telemedicine in the Operating Room: The ‘New Normal’ for MedTech

12/28/2020

Excerpt from the Article: There is incredibly high demand for collaboration during medical procedures – whether it’s a Cardiologist advising a more junior physician on a complex procedure, a renowned surgeon training other colleagues on a technique, a medical device company rolling out a new product, or a medical device rep providing product support during…

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Pear Therapeutics Announces First Participant Enrolled in Virtual Real-World Study of Adults with Chronic Insomnia

07/15/2020

Excerpt from the Press Release: “BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. today announced the first participant enrolled in an open-label, decentralized clinical trial (called the DREAM study) evaluating Somryst™, an FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia. The DREAM study will enroll approximately 350 adults in the United States with…

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