Good Clinical Practice (GCP) Compliance

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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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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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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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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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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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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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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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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Vendor and Technology Partner Governance in Virtual Trials Vendor and Technology Partner Governance in Virtual Trials In the evolving landscape of clinical research, ensuring compliance with regulatory standards while utilizing the benefits of technology is paramount. This article provides a comprehensive step-by-step guide on Vendor and Technology Partner Governance in the setting of virtual trials,…

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Inspection Readiness for Digital and Decentralized Clinical Programs Inspection Readiness for Digital and Decentralized Clinical Programs In the evolving landscape of clinical trials, digital and decentralized methodologies are gaining prominence. As clinical operations, regulatory affairs, and medical affairs professionals, ensuring inspection readiness for these innovative approaches is essential. This comprehensive guide outlines the steps necessary…

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