Tag: decentralized trials

Documenting Digital Workflows and Data Flows in Protocol and TMF Documenting Digital Workflows and Data Flows in Protocol and TMF In the evolving landscape of clinical research, where digital solutions are becoming increasingly prominent, it is crucial for clinical professionals to effectively document the workflows and data flows involved in clinical trials. This guide outlines…

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Monitoring and Source Verification in Decentralized Trial Models In recent years, the landscape of clinical research has undergone a transformative shift, particularly with the rise of decentralized trial models. The adaptation of digital technologies in clinical trials offers promising benefits and efficiency gains. However, implementing effective monitoring and source verification practices within decentralized models presents…

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Participant Safety and Signal Detection in Highly Digital Studies Participant Safety and Signal Detection in Highly Digital Studies Introduction to Participant Safety in Digital Clinical Trials The rise of highly digital studies, including decentralized clinical trials (DCTs), has transformed the landscape of translational clinical research, demanding a fresh perspective on participant safety and signal detection….

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Managing BYOD, Wearables and Sensor Data in Compliance With GCP Managing BYOD, Wearables and Sensor Data in Compliance With GCP In the evolving landscape of clinical research, the integration of Bring Your Own Device (BYOD) strategies and wearable technologies presents unique opportunities and challenges in data management and compliance. This comprehensive guide is geared towards…

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Investigator Responsibilities When Care Is Delivered Remotely Investigator Responsibilities When Care Is Delivered Remotely The shift towards remote care in clinical trials has fundamentally transformed the way that healthcare is delivered to trial participants. As clinical operations, regulatory affairs, and medical affairs professionals in the US, UK, and EU navigate this landscape, it’s essential to…

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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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