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Best Practices in Managing CGT From Protocol Design to Data ManagementThough the fields of immunotherapy and cell and gene therapies have seen significant growth since April 2012, CGT clinical research remains a challenge.
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Understanding Acceptability of eConsent from a Global, Ethical, and Industry PerspectiveUsing surveys to collect various viewpoints on eConsent from ethics, sponsors, and vendors.
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The State of the Clinical Trial Site Technology Industry: Examining Key TrendsFindings from Florence Healthcare’s State of Clinical Trial Technology Industry survey about how clinical operations technology changed in 2020 and how they expected it to evolve throughout this year.
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How Automation and Generative AI will Transform Clinical Trials in the Next 1-2 YearsDCTs, data, and analytics are all areas that could be impacted in the near future.
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Four Strategic Considerations to Choose an EDCCompanies share their experience in future-proofing clinical data technology.
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The Future of Personalized Medicine Hinges on Revolutionizing Business ModelsThe era of big pharma as product-first companies must end, as services become the larger priority.
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Spontaneous Reporting System for Adverse Drug Reactions in GermanyWhile underreported, ADR data offers significant value to the drug development value chain to refine the predictive capability and stability, and provide enhanced patient safety.
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Patient-Centered Recruitment and RetentionBy decentralizing trials whenever feasible, sites can decrease patient burden, clinops workload, and the number of on-site participants.
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eSource Interoperability Between EHR and EDCEvidence from a Phase III cancer trial points to notable advances in data-transfer tech.
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AI to Impact Clinical Trials and Manufacturing in Life SciencesArtificial intelligence may find a home in clinical trials and manufacturing in the coming years, but privacy, cyber security, and determining who owns the intellectual properties could pose challenges.
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Navigating a Decentralized Trial Model and the Changing Clinical Landscape During COVID-19A top-down analysis of the decentralized trial model’s benefits and impact on the industry.
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Where Innovation and Patients Meet to Improve Cancer CarePromising scientific advances are pacing oncology drug development.
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COVID-19 Pandemic Exemplifies the Benefits of CROsThe adaptability and innovative capacity of CROs highlighted in EUCROF survey.
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Enabling Evidence-Based Study Endpoint SelectionHarnessing advances in digital health technologies for a more precision-measured approach.
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Using Real-World Data in Patient RecruitmentGrowing availability of RWD leads new drug development process.
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Righting the Ship in 2024 and Beyond: Navigating the First Extended Workforce Recession in the History of the Life Sciences IndustryWebinar Date/Time: Tue, Tue, Nov 28, 2023 11:00 AM EST
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COVID-19 and Its Impact on the Future of Clinical Trial ExecutionFindings from a Tufts study examining the effects of COVID-19 on clinical trials.
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FDA Finalizes Decentralized Clinical Trial GuidanceThe FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
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Addressing Population Gaps in Therapy Adoption: Using Real-World Data to Bridge the Clinical Trial DivideHow clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.
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Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 3)Series Part 3—Methods for early detection of risk and summary.
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Preparing to Achieve with Joint Clinical AssessmentsStrategies for sponsors in navigating the European Union's new health technology assessment regulation.
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A pathway for replacing costly TQT studiesBolstered by the recently approved S7B/E14 Q&A document, early-stage concentration-QTc analysis is emerging as a standard for assessing cardiac safety.
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Accelerating Research Site OperationsLessons learned during the pandemic from University of Louisville.
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COVID-19 Pandemic Exemplifies the Benefits of CROsThe adaptability and innovative capacity of CROs highlighted in EUCROF survey.
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The Argument for Data Alignment and Integration in Clinical Supply ManagementSiloed systems can make it difficult to marry data to support timely and informed decision-making and optimize clinical trial operations.
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Leveraging Lessons Learned From the First Decade of Modern Immuno-OncologyWhich new developments can help jump-start breakthroughs in immuno-oncology research? Understand the key scientific drivers, read peer-reviewed research, and get actionable ideas that can spur innovation in this must-read paper for clinical leaders.
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Consequences of Brexit for Clinical Trials in EuropeHigher costs headline list of new challenges faced by CROs and sponsors.
