Learn more about Lindus Health from our blog page. Our posts cover an array of topics from clinical developments to diversity.
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.
Delve into the world of clinical trials with our comprehensive guide, unraveling the definitions, phases, and significance of these pivotal studies in advancing medical science and ensuring patient safety..
Discover the ins and outs of clinical testing with our comprehensive guide.
Discover the essential criteria for selecting the ideal Contract Research Organization (CRO) for vaccine development.
Discover how Infectious Disease CRO services are revolutionizing clinical research by boosting efficiency and accelerating drug development.
Discover how CRO ophthalmology is transforming clinical research in eye care, enhancing treatment outcomes, and accelerating innovation.
Discover the top vaccine Contract Research Organizations (CROs) of 2024 that are at the forefront of innovation and excellence.
Explore how Vaccine CROs are revolutionizing clinical research and development, accelerating vaccine innovation, and ensuring safety and efficacy in the fight against global health challenges.
Discover the key factors to consider when selecting a CRO for asthma studies.
This blog covers key takeaways from the FDA's final guidance on decentralized clinical trial execution.
Explore the critical role of Phase 4 trials in clinical research, where post-marketing studies enhance drug safety and efficacy.
Dive into the intricate world of clinical trial regulation with our comprehensive guide.
Discover essential best practices and innovative strategies for effective data management in clinical research.
Discover the essential distinctions between Phase 1 and Phase 2 in our comprehensive guide.
Discover the essential distinctions between Phase 2a and 2b clinical trials in our comprehensive guide.
Dive into our comprehensive guide on IDE clinical trials, where we unravel the complexities of Investigational Device Exemptions.
Discover how Clinical Trial Management System (CTMS) software revolutionizes clinical trials by enhancing efficiency, improving data accuracy, and streamlining collaboration.
Discover innovative and effective strategies for recruiting participants in clinical trials.
Unlock the secrets to a flawless IDE submission with our comprehensive step-by-step guide.
Discover innovative and effective strategies for enhancing patient recruitment in clinical research.
Discover innovative and proven strategies to enhance patient recruitment for clinical trials in this comprehensive article.
Discover how Electronic Data Capture (EDC) is revolutionizing clinical trials by streamlining data collection, enhancing accuracy, and accelerating research timelines.
Explore the essential world of clinical data management in our comprehensive article.