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.
Digital Therapeutic Clinical Trials (DTx) signify a rapidly evolving domain in healthcare, leveraging advanced software-based interventions to prevent, manage, and treat a spectrum of diseases and disorders. This article delves deep into the role, challenges, and future trajectory of digital therapeutic clinical trials, including the process for obtaining FDA and other regulatory approvals, the economic implications of therapies, and data collection for marketing claims. It also explores the role of Contract Research Organizations (CROs) in executing these studies and the advantage conferred by decentralized approaches.
Digital Therapeutics (DTx) is a rapidly evolving field that is reshaping the landscape of healthcare and medicine. In essence, these are evidence-based therapeutic interventions that employ high-quality software programs to prevent, manage, or treat a broad range of physical, mental, and behavioral conditions.This article takes a deep dive into the world of digital therapeutics, exploring its definition, the role of clinical trials in its development and commercialization, and the importance of a digital therapeutics Contract Research Organization (CRO) in executing these studies.
Explore the pivotal role of a Principal Investigator in a clinical trial, from overseeing research activities to ensuring ethical standards.
Discover the essential strategies and best practices for successful patient recruitment in clinical trials.
Discover how a Clinical Trial Management System (CTMS) plays a crucial role in streamlining and optimizing the complex processes of clinical trials.
Delve into the world of drug development and the fascinating mechanisms of action of NGMs, while exploring the crucial role of maleimides.
Discover the latest advancements in cystic fibrosis clinical trials and how they are revolutionizing treatment options for patients.
Discover effective strategies for overcoming the key challenges in enrolling pediatric patients in hepatoblastoma clinical trials.
Discover how Contract Research Organizations (CROs) play a crucial role in overcoming challenges in rare disease trials through strategic site selection.
Discover the secrets to mastering sales and customer satisfaction as we delve into an exclusive interview with Carlos Naranjo, the Director of Sales at Vial.
Discover the top neurology startups leading the biotech revolution.
Discover how the ESM Metagenomic Atlas is transforming drug discovery by revolutionizing protein structure prediction.
Discover the essential steps for navigating Health Canada's regulatory submission requirements for clinical drug trials in this comprehensive guide.
Discover the crucial role of assessment tools in dermatology clinical trials with this comprehensive guide.
Discover why Lipinski's Rule of Five is crucial in drug discovery.
Discover the groundbreaking potential of indomethacin as a cutting-edge therapy for pancreatitis in this insightful article.
Discover how artificial intelligence is revolutionizing the field of gastroenterology, particularly in the realm of GERD clinical trials.
Discover how digital therapeutics are emerging as validated, evidence-based treatments to manage and treat prevalent chronic conditions.
Learn how to conquer the hurdles of biotech sponsorship with our comprehensive guide.
Discover the latest advancements in ALS research and explore the cutting-edge clinical trials for emerging therapies.
Discover effective strategies for overcoming challenges in recruiting participants for MCC clinical trials.
Discover 5 innovative strategies for sustainable drug discovery and reducing environmental impact in the pharmaceutical industry.