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Designing a New Operational Model for Decentralized Clinical Trials as the New Normal

Over the last two decades, clinical trials have started to adopt patient-centric practices by incorporating virtual/remote technologies, shifting from the so-called traditional clinical trial model to an increasingly decentralized approach. As digital tools and remote practices have become woven into the fabric of these studies, the operational model has also transformed to reflect the dynamic nature of decentralized clinical trials (DCTs). This article discusses the shift to this "new normal" and outlines several considerations for assessing current operating procedures, incorporating DCT processes and creating a standard construct going forward to build more efficient, flexible trials centered around the needs of providers and patients.