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Perspectives on clinical study design, execution, and delivery.
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Bringing Your Cancer Diagnostics to Market: Strategies for Success
Cancer diagnostics are entering a pivotal era, with advances in genomics, AI, and non-invasive testing reshaping how and when we detect disease.
Psychedelics in Clinical Trials: A Promising Frontier in Mental Health Treatment
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.
Medicine’s Blind Spot: How Clinical Trials Are Failing Women
From insulin to immunotherapies, clinical trials have powered some of the most important medical breakthroughs of our time.
IVDD to IVDR: A Sponsor’s Guide to Europe’s Diagnostic Revolution
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.
How to Build a Go-to-Market Strategy for Your IVD
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.
Medical Device Marketing EU vs US: Why Your Launch Strategy Needs a Continental Divide
For medical device companies looking to grow globally, expanding into both the US and EU often feels like the logical next step. But many teams quickly learn that what works in one region doesn’t always translate to the other. Despite some similarities, the US and EU operate within different regulatory and commercial frameworks.
GLP-1 Agents: Expanding Therapeutic Horizons Beyond Diabetes and Weight Management
GLP-1 receptor agonists are quickly becoming versatile treatments with proven effectiveness in cardiovascular disease, chronic kidney disease, sleep apnea, and Alzheimer’s Disease. Early clinical data suggest they may also help in neurodegeneration, osteoarthritis, and other inflammatory conditions, making this drug class a potential game-changer in metabolic medicine, where specialized CRO support is critical for navigating complex clinical development.
CGM Use Outside Diabetes: The Rise of Personalized Metabolic Medicine
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.
5 Trends Shaping the Future of Medical Device Clinical Trials
Discover strategies and considerations that ahead-of-the-curve medical device research teams are using in their clinical trials.
Why Strategic Integration is an Absolute MUST for Your Medical Device Research
Discover how harmony between your commercial, regulatory, and clinical development strategies sets your medical device trial up for success.
