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.
Psychedelics are reshaping mental health treatment, with over 100 active psilocybin trials reflecting renewed interest after decades of stalled progress due to stigma and regulation.
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.
The world of healthcare and medicine is continually evolving, with digital technologies leading the charge in modern advancement. One such innovation is Digital Therapeutics (DTx), a new class of software-based therapeutic interventions that aim to prevent, manage, or treat a broad spectrum of diseases and disorders. DTx offers an array of benefits, including increasing patient access to clinically safe and effective therapies, reducing healthcare costs, and extending clinicians' ability to care for patients.
Clinical trials are a pivotal phase in the development and approval of a new medical device. They provide critical data on the safety and effectiveness of the device, which is essential for securing regulatory approvals and gaining market acceptance. One of the most critical aspects of planning and implementing a clinical trial is budgeting. This article will demystify the average cost of clinical trials for medical devices and offer insights into the various cost components and factors that can impact the overall budget.
Explore the critical process of database lock in clinical trials with our comprehensive guide.
Unlock the complexities of clinical trial statistics with our comprehensive guide.
Explore how Good Clinical Practice (GCP) guidelines shape the landscape of clinical trials, ensuring compliance, enhancing quality, and safeguarding participant welfare.
Explore the pivotal role of Site Management Organizations (SMOs) in clinical trials, uncovering how they streamline processes, enhance efficiency, and ensure compliance, ultimately accelerating the path to medical breakthroughs.
Explore how Electronic Data Capture (EDC) systems are revolutionizing clinical research by boosting data accuracy and operational efficiency.
Discover how to craft a robust regulatory strategy that drives business success.
Explore the critical role of Clinical Phase 4 in drug development, focusing on post-market surveillance.
Explore the intricate journey of drug development, from initial discovery to market approval.
Delve into the world of Clinical Trial Management Systems (CTMS) with our comprehensive guide.
Navigate the complex process of obtaining FDA approval with ease.
Unlock the complexities of the FDA and NDA processes with this comprehensive guide.
Discover how Electronic Data Capture (EDC) systems are revolutionizing clinical trials by enhancing data accuracy, streamlining processes, and accelerating research outcomes.
Explore the transformative advantages of Electronic Data Capture Systems in modern data management.
Explore the critical role of Phase IV clinical trials in drug development, uncovering how they ensure long-term safety and effectiveness post-approval.
Discover the leading EDC software solutions revolutionizing clinical trials in 2025.
Discover the innovative world of adaptive clinical trials, where flexibility and efficiency meet in medical research.
Explore the intricate journey of pharmaceutical drug development in this comprehensive guide.
Discover the essential features that make clinical trial management software effective and efficient.
Explore the pivotal role clinical sites play in medical research, from facilitating groundbreaking studies to ensuring patient safety and data integrity.
Discover the intricate timeline of clinical trials with our comprehensive guide.