Tag: clinical trials

Vendor and Partner Governance for Technology-Enabled DCT Sites

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Vendor and Partner Governance for Technology-Enabled DCT Sites Vendor and Partner Governance for Technology-Enabled DCT Sites The landscape of clinical trials is rapidly evolving, particularly with the rise of technology-enabled decentralized clinical trials (DCT). As clinical research organizations (CROs) and sponsors increasingly implement DCT and hybrid models, the need for robust vendor and partner governance…

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Oversight of DCT/Hybrid Sites

Training and Qualification of Non-Traditional Site Staff in DCT Models

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Training and Qualification of Non-Traditional Site Staff in DCT Models Training and Qualification of Non-Traditional Site Staff in DCT Models In the evolving landscape of clinical trials, decentralized clinical trial (DCT) models are increasingly becoming the norm. This shift requires thoughtful strategies for the training and qualification of non-traditional site staff. As clinical trials become…

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Oversight of DCT/Hybrid Sites

Audit Trail Exports, Retention and Readability for Inspections

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Audit Trail Exports, Retention and Readability for Inspections Audit Trail Exports, Retention and Readability for Inspections Introduction to Audit Trails in Clinical Trials In the realm of clinical trials, maintaining data integrity and ensuring compliance with regulatory standards is paramount. Audit trails serve as a foundational component to achieve these goals, providing transparent documentation of…

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Audit Trails & Access Controls

Access Control Considerations for Decentralized and Remote Study Models

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Access Control Considerations for Decentralized and Remote Study Models Access Control Considerations for Decentralized and Remote Study Models With the increasing adoption of decentralized and remote study models in clinical research, understanding access control considerations has become imperative for clinical operations, regulatory affairs, and medical affairs professionals. This article provides an in-depth, step-by-step tutorial on…

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Audit Trails & Access Controls

Treatment Policy, Hypothetical and Composite Estimands: When to Use Each

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Treatment Policy, Hypothetical and Composite Estimands: When to Use Each Treatment Policy, Hypothetical and Composite Estimands: When to Use Each In the realm of clinical research, particularly in the context of regulatory compliance and biostatistics, the concept of estimands has gained significant attention. Estimands provide a structured way to describe the treatment effect in clinical…

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Estimands & Handling Intercurrent Events

Oversight Strategies for Direct-to-Patient IP Shipments and Returns

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Oversight Strategies for Direct-to-Patient IP Shipments and Returns Oversight Strategies for Direct-to-Patient IP Shipments and Returns Clinical trials have increasingly embraced direct-to-patient (DTP) strategies, facilitated by advancements in logistics and technology. DTP clinical trials offer significant benefits, including enhanced patient engagement, expanded access to investigational products (IPs), and reduced site burden. However, they introduce unique…

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Oversight of DCT/Hybrid Sites

Central Monitoring Approaches Tailored to DCT/Hybrid Ecosystems

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Central Monitoring Approaches Tailored to DCT/Hybrid Ecosystems Central Monitoring Approaches Tailored to DCT/Hybrid Ecosystems As clinical trials increasingly adopt decentralized clinical trial (DCT) methodologies and hybrid approaches, the need for robust central monitoring techniques becomes paramount. This article serves as a comprehensive guide for clinical operations, regulatory affairs, and medical affairs professionals, detailing effective central…

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Oversight of DCT/Hybrid Sites

Detecting and Investigating Suspicious User Activity in Clinical Systems

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Detecting and Investigating Suspicious User Activity in Clinical Systems Detecting and Investigating Suspicious User Activity in Clinical Systems In the landscape of clinical research, ensuring the integrity of data and the security of clinical trial systems is paramount. With the increasing reliance on electronic data capture (EDC) systems in clinical trials, the need to detect…

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Audit Trails & Access Controls

Integrating Access Management With HR, IT and Vendor Onboarding Processes

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Integrating Access Management With HR, IT and Vendor Onboarding Processes Integrating Access Management With HR, IT and Vendor Onboarding Processes In the contemporary landscape of clinical trials, meticulous management of access controls is critical. As organizations progress to align their operational processes, particularly Human Resources (HR), Information Technology (IT), and vendor onboarding, there is an…

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Audit Trails & Access Controls

Identifying and Classifying Intercurrent Events That Impact Endpoints

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Identifying and Classifying Intercurrent Events That Impact Endpoints Identifying and Classifying Intercurrent Events That Impact Endpoints In the realm of clinical trials, understanding intercurrent events and their potential impact on study endpoints is crucial. This article aims to provide clinical operations, regulatory affairs, and medical affairs professionals with a thorough, step-by-step guide to identifying and…

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Estimands & Handling Intercurrent Events