Decentralized Trials
Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the first patient has been dosed at City of Hope…
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Key Points The results of an early-stage clinical trial investigating focused ultrasound to address a possible underlying cause of Parkinson’s disease were published in Movement Disorders. Researchers in Toronto tested the safety and efficacy of focused ultrasound–induced blood-brain barrier opening to deliver enzyme replacement therapy. The procedure was well-tolerated, and a larger study is being…
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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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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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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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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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