Digital devices can streamline clinical trials and improve the patient experience, but devices used in clinical trials must be safe, reliable, effective and compliant with rigorous regulatory standards, writes Vicki Gashwiler, director of strategic development at Novella Clinical. The Clinical Trials Transformation Initiative is developing a framework for using digital sensors and biomarkers in clinical trials in collaboration with the pharmaceutical and technology industries, contract research organizations and regulatory agencies, Gashwiler notes.
Efforts underway to maximize digital tools in clinical trials
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