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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.
Discover the leading clinical data management software solutions set to revolutionize healthcare in 2025.
Unlock the secrets to obtaining FDA approval with this comprehensive step-by-step guide.
Discover a comprehensive guide to creating a medical device clinical trial protocol with this detailed example.
Discover the ins and outs of medical device clinical trials and gain a comprehensive understanding of the associated costs.
Learn how to make the most of your medical device clinical trial budget with these expert tips and strategies.
Explore the intricacies of FDA medical device clinical trial regulations in this comprehensive article.
Discover the key elements of designing effective clinical trials for medical devices in this comprehensive guide.
Discover the ins and outs of the medical device clinical trial process with our comprehensive guide.
Discover the factors that impact the cost per patient for medical device clinical trials in this insightful article.
Discover how ePRO streamlines the data collection process and enhances consumer health research.
Explore the vital role of consumer health clinical trials in advancing medical research and improving patient care.
Discover the latest clinical trials analysis on cold and flu products, exploring their efficacy and impact.
Explore the latest developments in cold and flu clinical trials, and discover everything you need to know about potential treatments, research methodologies, and the future of combating these common illnesses.
Stay ahead of the curve with the latest findings from dietary supplement clinical trials.
Discover how cosmetic clinical trials play a crucial role in advancing beauty science.
Discover the profound effects of dietary clinical trials with this comprehensive overview.
Discover the cutting-edge findings from the newest baby formula clinical trials in this insightful article.
Discover the most recent advancements in allergy medications through clinical trials.
Discover the numerous advantages of partnering with an Exercise Supplement Contract Research Organization (CRO) in this insightful article.
Discover how wellness products contract research organizations can revolutionize the development of health and wellness products.
Stay ahead of the curve with our in-depth look at the latest advancements in eye care.
Discover the groundbreaking findings from the latest hair care clinical trials in our comprehensive article.