CLINICAL TRIAL COMPLIANCE & OPERATIONS TECHNOLOGY INSIGHTS
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Enhancing Clinical Trial Efficiency & Compliance With eQMS
In recent years, electronic quality management systems (eQMS) have emerged as powerful tools to streamline and enhance the quality control processes in clinical trials. This article explores the key components, benefits, challenges, and future of eQMS in the context of clinical trials.
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RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct.
IRT RESOURCES
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Interactive response technology (IRT) systems ensure clinical trial participants receive the correct treatment, facilitate enhanced logistics tracking, and empower users to obtain real-time data.
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Explore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.
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The pharmaceutical industry is full of acronyms. Gain insight into the evolution of the acronyms, the technology and the terminology, specifically for RTSM (Randomization and Trial Supply Management).
RBQM RESOURCES
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Examine how Medidata's Clinical Operations solutions are working to improve the efficiency of study timelines through their platform, guided by interconnected workflows and data-driven insights.
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This paper highlights why the industry is moving towards RBQM and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies.
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Tanya du Plessis, VP of Data Solutions and Strategies at Bioforum, and Rich Davies, VP of Solutions Expert at CluePoints, explain the principle applications of RBQM to Data Management.
RTSM RESOURCES
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Electronic data capture (EDC) is straightforward, in theory. However, not every EDC is purpose-designed for ease of use by study teams, and some are easier to use and more intuitive than others.
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With so many moving parts in a clinical trial, why worry about the technology that is supposed to help manage it? In this webinar, explore five actionable and necessary strategies to leverage RTSM to simplify clinical trial operations.
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Unearth the ways electronic clinical outcome assessment technology is revolutionizing data collection, improving patient experiences, and enhancing trial outcomes.
EREG RESOURCES
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By addressing the unique hurdles tied to regulations in European clinical trials, eBinders offer a streamlined approach to managing electronic trial documentation.
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Unearth the different kinds of eRegulatory use cases for diverse clinical site types and other eRegulatory capabilities designed to serve all sites.
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Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.
PAYMENT RESOURCES
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Unearth how bringing the functions of medical writing, clinical data management, and electronic data capture can positively impact the creation of a budget and payment process.
IRT SOLUTIONS
RBQM SOLUTIONS
RTSM SOLUTIONS
EREG SOLUTIONS
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Take advantage of this checklist for evaluating eRegulatory solutions for clinical trial offices.