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The global in vitro diagnostics (IVD) market is evolving rapidly, driven by growing demand for faster, more accessible testing across clinical and consumer settings. As healthcare systems shift toward earlier detection, personalised treatment, and decentralised care, the need for innovative diagnostics has never been greater. Yet turning a concept into a market-ready product remains a lengthy process. For sponsors looking to successfully launch their diagnostic products, creating an effective go-to-market strategy (GTM) and partnering with specialized contract research organizations (CROs) can make the difference between market success and costly delays.
The transition from IVDD to IVDR represents the most significant regulatory change for diagnostic devices in Europe in decades. With extended transition periods now in place, clinical study sponsors face both new challenges and opportunities. Understanding the evolving requirements is essential to staying compliant and keeping studies on track.
The continuous glucose monitor (CGM) has evolved far beyond its original purpose as a diabetes management tool. Recently, the FDA cleared the first over-the-counter CGM intended for anyone 18 years and older who does not use insulin, including those without diabetes who want to better understand how diet and exercise impact blood sugar levels. This landmark approval has opened new frontiers in personalized medicine, where metabolic insights drive precision health interventions.
Discover how tailored recruitment models—fully decentralized, hybrid, or traditional clinical sites—can optimize enrollment speed, data quality, and cost efficiency in your oncology diagnostics trial.
Unravel the complexities of clinical trial regulations with our comprehensive guide for researchers and sponsors.
Discover the crucial role of cardiac imaging and why it is essential for understanding heart health.
Discover the pivotal role of medical devices clinical trials in ensuring the safety and efficacy of healthcare innovations.
Explore the crucial role of adverse event reporting in medical device clinical trials.
Discover the intricate process of clinical trials for medical devices and gain insight into the timeline and factors that influence their duration.
Explore the comprehensive guide to the phases of medical device clinical trials, delving into the intricate process from conception to market approval.
In this comprehensive guide, explore the intricate world of clinical trials for medical devices and uncover the true cost behind the groundbreaking research.
Discover the crucial role of Phase 1 clinical trials in the development of medical devices.
Learn everything you need to know about conducting clinical trials for medical devices in Europe with this comprehensive guide.
Discover the impact of over-the-counter medications on clinical trials in this informative article.
Unlock the secrets behind the significance of clinical trials for medical devices.
Looking for the best medical devices CRO companies? Our comprehensive guide has you covered! Explore the top players in the industry, their services, and how they can help bring your medical device to market.
Explore the dynamic landscape of the medical device CRO market in this insightful article.
Discover how consumer health clinical research is streamlined through ePRO.
Discover the essential requirements for conducting clinical trials on medical devices with this comprehensive guide.
Discover why clinical trials are crucial for the development and validation of medical devices.
Discover the step-by-step process of conducting medical device clinical trials with our comprehensive timeline.
Uncover the essential insights on whether medical devices necessitate clinical trials in this comprehensive article.
Discover the ins and outs of FDA medical device clinical trial guidance with this comprehensive overview.
Discover the importance of clinical trials for medical devices and explore the regulatory requirements and ethical considerations.
Discover everything you need to know about clinical trials for medical devices in this comprehensive guide.
Discover the critical role of medical device clinical trials in ensuring the safety and efficacy of healthcare innovations.