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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.
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.