CLINICAL TRIAL COMPLIANCE & OPERATIONS TECHNOLOGY INSIGHTS
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Developing A Risk-Based Model For Computer System Validation
Consultant Richie Siconolfi explores risk factors that can be used to develop a risk-based approach to computer system validation.
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3 FDA Guidance Documents That Shaped Today's Computer System Validation
Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.
IRT RESOURCES
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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.
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Watch this process video to see how IQVIA’s integrated Interactive Response Technology (IRT) and electronic Clinical Outcome Assessment (eCOA) solution combined with unified platform delivery drives study orchestration and optimization.
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Get acquainted with IRT in areas such as no-code study deployment, automated excursion reviews, rapid prototyping, AI-enabled datasets, reduced (or removed) change orders, and more.
RBQM RESOURCES
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Clinical data innovators prioritize risk-based quality management, standards, and closer collaboration with research sites. Many see AI as an important support rather than a top priority.
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Explore how digital health technologies offer a data-driven solution to cytokine release syndrome (CRS) monitoring, reducing inpatient care requirements while ensuring patient safety.
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Performance metrics for supporting risk-based management can be great, however, this author tells readers why collecting and analyzing data after a study has begun may not be the best approach.
RTSM RESOURCES
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Learn about the strategy and successful execution of a complex randomization design that helped LG Chem overcome its clinical trial challenges alongside eClinical randomization experts.
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Streamlined supply chain operations alleviate staff workload and significantly reduce IP waste. With the right partners, you can create a fully optimized, cost-effective supply chain strategy.
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Explore the need for advanced capabilities beyond basic RTSM and the importance of having experienced teams behind IRT solutions to navigate complexities and ensure successful trial execution.
EREG RESOURCES
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Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
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Explore the critical process of Study Start-Up (SSU) in clinical trials, with an emphasis on the collaborative efforts of sponsors and research sites to enhance efficiency and reduce timelines.
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Electronic clinician-reported outcomes (eClinROs) enhance the quality and consistency of clinical trial data. Discover key factors to consider when selecting an eClinRO provider.
PAYMENT RESOURCES
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Discover how Greenphire's innovative payment solutions can transform your clinical trial operations and ensure site sustainability.
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Managing participant payments in clinical trials is a multifaceted challenge impacting participants, sites, and sponsors alike. Delve into the intricacies and numerous hurdles faced in this process.
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Learn about the evolving U.S. clinical trial site market landscape including a detailed analysis of ownership models, market segmentation, and the role of financial investors in acquisitions.
IRT SOLUTIONS
RBQM SOLUTIONS
RTSM SOLUTIONS
EREG SOLUTIONS
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Hassan Khalid of AstraZeneca and Jessica Jolly, a senior data and science executive, talk about the advantages of automation as a result of a Guidance like ICH M11, and why “automation” is not synonymous with AI in this case.
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Jessica Jolly, a senior data and science executive, is challenging CDOs (chief data officers) and CDAOs (chief data & analytics officers) to stop putting the data science community “to sleep” with the traditional monotonous SOPs, and instead, move more toward autonomous governance by design.
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Take advantage of this checklist for evaluating eRegulatory solutions for clinical trial offices.
PAYMENT SOLUTIONS
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Enhance your Clinical Trial Payments solution with IQVIA Forecasting to leverage our global expertise and navigate the complexities of payments with ease.
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In today’s ever-evolving clinical trial space, managing the expenses associated with conducting a study is more important – and fraught – than ever before.
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Integrate data from all industry sources to confidently plan budgets for studies worldwide, across all phases and therapeutic areas.