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The Roadmap to Clinical, Regulatory, and Commercial Success in Medical Device Clinical Trials

White Paper

The Roadmap to Clinical, Regulatory, and Commercial Success in Medical Device Clinical Trials

By Medidata

The Roadmap to Clinical, Regulatory, and Commercial Success in Medical Device Clinical Trials

By Medidata
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Over the past two decades, digital technology has transformed almost every industry and altered the nature of daily life at an incredible pace. In the highly regulated medical device industry, companies eyed digital strategies cautiously as they emerged.

The COVID-19 pandemic exacerbated the challenges that medical device clinical trials always faced, including
finding a regulatory pathway, managing disparate data sources, and reaching commercial success. A number of
factors have applied significant pressure on medical device manufacturers to adopt cutting-edge eClinical technology systems to create more efficiencies and to effectively manage clinical trial data. These factors include an increased push toward decentralization of clinical trials and use of advanced analytics, continued fragmentation of clinical trial data collection, and ongoing and significant changes in the international regulatory environment. Although technology may not resolve all issues regarding medical device clinical trials, many new tech approaches can help medical device companies achieve clinical, regulatory, and commercial success with greater efficiencies, adherence to timelines, and cost savings.

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