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EMA Offers Clarity on Digital Biomarker Terminology and Submission Process
Earlier this month, the European Medicines Agency (EMA)’s Human Medicines Division issued “Questions and Answers: Qualification of Digital Technology-Based Methodologies to Support Approval of Medicinal Products.” The Q&A explains considerations... Download
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COVID-19: Considerations and Implications for Digital Biomarkers in Clinical Trials
The use of remote digital measures — sensors, wearables, and other non-invasive remote measurement tools — is a key component of how researchers will respond to the COVID-19 pandemic. The…
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Digital Health Technology, Remote Clinical Trials and COVID-19: Koneksa Speaks at Forum
Remote clinical trials are especially important in light of the COVID-19 pandemic, and the U.S. Food & Drug Administration has issued guidance for clinical trials during this time. On March…
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