Blog

Introduction As digital health tools — such as wearables, mobile apps, and AI-driven platforms —become integral to clinical trials, regulatory agencies are evolving their frameworks to ensure these innovations align with Good Clinical Practice (GCP). This post explores how the FDA, EMA, and ICH are adapting GCP guidelines to accommodate digital technologies, while maintaining the core principles of participant safety,…
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Introduction The integration of wearable technologies and digital biomarkers into clinical trials is revolutionizing how we collect, monitor, and interpret health data. From smartwatches tracking heart rate variability to continuous glucose monitors and digital inhalers, these tools offer real-time, patient-centric data. But with innovation comes responsibility — particularly in adhering to Good Clinical Practice (GCP)…
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Global Experts in GxP Regulatory Compliance At ClinAudits, LLC, we specialize in providing customized auditing, monitoring, and quality assurance services to pharmaceutical, biotechnology, and medical device companies worldwide. With over three decades of experience, our team of seasoned professionals ensures that your clinical trials meet the highest regulatory and ethical standards. Our Core Service Offerings…
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ClinAudits’ Audit Notes Sponsor Oversight in Outsourced and Virtual Trial Models – Raising the Bar in GCP Auditing As the clinical research landscape rapidly evolves, sponsors are increasingly outsourcing operational responsibilities to CROs, technology providers, and virtual trial vendors. While this model offers scalability and innovation, it also introduces new complexities in Good Clinical Practice…
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