Tag: digital health

Oversight Models for Home Health, Direct-to-Patient Shipments and Local Labs Oversight Models for Home Health, Direct-to-Patient Shipments and Local Labs The evolution of clinical trial practices has been significantly impacted by innovations in technology, particularly in the areas of home health, direct-to-patient shipments, and local laboratory utilization. As clinical operations professionals, along with regulatory and…

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Validating Digital Platforms Under GCP and Computer System Validation Validating Digital Platforms Under GCP and Computer System Validation In recent years, the rapid advancement of digital technologies has transformed the landscape of clinical research. With the advent of mobile applications, electronic data capture (EDC) systems, and decentralized clinical trial approaches, the need for robust validation…

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Regulatory Expectations for eConsent, Telemedicine and Remote Visits Regulatory Expectations for eConsent, Telemedicine and Remote Visits In recent years, the landscape of clinical trials has undergone a significant transformation, particularly with the advent of digital technologies. This change is characterized by an increasingly common integration of eConsent, telemedicine, and remote visits into clinical trial methodologies….

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Data Integrity and Privacy Controls in App- and Device-Driven Studies Data Integrity and Privacy Controls in App- and Device-Driven Studies In recent years, clinical trial methodologies have evolved significantly with the advent of technology. App- and device-driven studies, often referred to as digital or decentralized clinical trials, are becoming more prevalent due to their potential…

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Applying GCP Principles in Digital and Decentralized Clinical Trials Applying GCP Principles in Digital and Decentralized Clinical Trials Clinical trials have evolved significantly with the advent of technology, leading to the emergence of digital and decentralized clinical trials (DCTs). These trials utilize various digital resources and methodologies to improve patient engagement, data collection, and overall…

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