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Founder, CEO @ Delve Health | Healthcare Technology, Clinical Research, Digital Health, Wearables guru, Digital Endpoints, Next Gen Patient Outcomes

As the clinical trial industry continues to evolve under the digital transformation umbrella, it's clear that this journey might take longer than initially anticipated. The rapid adoption of direct-to-patient models during the 2020 pandemic highlighted both possibilities and pitfalls in patient engagement and regulatory compliance. Despite guidance from the FDA to streamline this transition, integrating new digital approaches into the highly regulated framework of clinical trials presents a myriad of challenges. Regulatory roadblocks, patient compliance, and agile implementation hurdles are just a few of the obstacles faced by the sector. The reality is that while the healthcare sector recognizes the immense benefits of digital transformation, the actual implementation is lagging. The agility promised by digital tools is often anchored down by the very systems it aims to improve. So, what’s the way forward? It’s time for a collaborative push. We need to leverage technology not just as a tool, but as an integral part of a redefined trial process that aligns with regulatory standards and meets patient needs efficiently. How are your organizations dealing with the transition? Are there lessons that can help us navigate these waters more effectively? #ClinicalTrials #DigitalTransformation #HealthcareInnovation #FDA #AgileDevelopment

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