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.
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.
Clinical trial companies are the unsung heroes in the world of medical development. These organizations play a pivotal role in research and development (R&D) phase by providing support during the various stages of the clinical trial process. In essence, clinical trial companies are the bridge between pharmaceutical companies and the healthcare industry, providing a platform for much-needed medical solutions to come to fruition.
The clinical research ecosystem is a complex network of various stakeholders, including sponsors, investigators, patients, regulators, and a host of service providers known as clinical research vendors. These vendors play a critical role in ensuring the successful execution of clinical trials, and their expertise ranges from full-service delivery of clinical trials (CROs), patient recruitment, to mobile nursing and phlebotomy. This article aims to delve into the different categories of clinical research vendors, highlighting top players in each category.
Discover the key factors in selecting the best Electronic Data Capture (EDC) systems for clinical trials.
Discover the essentials of Clinical Trial Management Systems (CTMS) in this comprehensive guide.
Delve into the intricacies of Phase IIa clinical trials with our comprehensive guide, exploring their pivotal role in drug development, key insights, and the broader implications for medical research and patient care..
Explore the transformative effects and far-reaching implications of the IDE Trial in this insightful article.
Explore the key distinctions between Phase 1 and Phase 2 clinical trials in this insightful article.
Explore the intricate journey of drug development with our comprehensive guide, detailing each critical stage from discovery to market approval.
Explore how a groundbreaking clinical trial can shape the future of drug approval processes, influence regulatory decisions, and redefine treatment standards in the pharmaceutical industry..
Unpacking the FDA's latest warning on unauthorized HIV blood self-collection kits.
Discover the essential features that make a Clinical Data Management System effective and reliable.
Discover proven strategies to enhance participant recruitment in clinical research.
Discover the intricate timeline of clinical trials, from initial research to final approval.
Discover the essential best practices and cutting-edge tools for optimizing clinical trial data management.
Explore the critical role of Phase IV clinical studies in drug development, uncovering how they ensure long-term safety and efficacy of medications post-approval.
Explore the intricate world of clinical research with our essential guide.
Explore the transformative landscape of clinical research services as innovation unlocks new possibilities.
Dive into the fascinating world of clinical research with our comprehensive guide, exploring its various types and their pivotal roles in advancing medical science and improving patient care.
Navigate the intricate world of drug approval with our comprehensive guide to the NDA New Drug Application process.
Dive into the fascinating world of medical research with our comprehensive guide.
Explore the intricacies of parallel study design with our comprehensive guide.
Navigate the complexities of Good Clinical Practice (GCP) regulations with our comprehensive guide.