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The PUEKS Project: Process Innovation in Clinical Trial MonitoringA look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.
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A Comprehensive Approach to Accelerating Clinical Trial EnrollmentIt is well documented that lengthy start-up at individual trial sites related to contracting and committee reviews contributes significantly to delays.
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Discussion on TransCelerate’s QMS InitiativeTransCelerates work on their clinical trial Quality Management Systems (QMS) initiative began about one year ago. This article summarizes findings from a recent DIA publication about the initiative and evaluates potential issues during QMS framework implementation.
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Endpoint Adjudication of Events Charter Template: What Should Be Included?Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.
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BlockChain in Clinical Trials—the Ultimate Data NotaryAssessing the benefits of using blockchain technology as a notary service in the network sharing of clinical data.
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A Comprehensive Approach to Accelerating Clinical Trial EnrollmentIt is well documented that lengthy start-up at individual trial sites related to contracting and committee reviews contributes significantly to delays.
Latest:
The PUEKS Project: Process Innovation in Clinical Trial MonitoringA look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.
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Why Smart Statistics Can Save PharmaFundamental weaknesses of modern clinical development can be resolved through recent statistical advances.
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Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase TrialsThe drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.
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Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase TrialsThe drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.
Latest:
Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase TrialsThe drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.
Latest:
Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase TrialsThe drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.
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The Drive for Technical Innovation – Addressing Clinical Study ChallengesTechnology now provides many advances that can determine the future of clinical trials. How sponsors, vendors, regulators and new entrants to the sector manage this transition will determine how effectively the industry adopts these tools.
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Capturing Suicidal Patient DataMeeting FDA requirements: the electronic collection of suicidal ideation and behavior data.
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Is South Korea the Next Emerging Early Phase Destination?The developed markets of North America and Europe together saw approximately 81% of the Phase I trial share in 2013 which is a 6% increase from 2012. Trials
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Is South Korea the Next Emerging Early Phase Destination?The developed markets of North America and Europe together saw approximately 81% of the Phase I trial share in 2013 which is a 6% increase from 2012. Trials
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Satisfaction of Healthy Subjects in Phase I TrialsSurvey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.
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Satisfaction of Healthy Subjects in Phase I TrialsSurvey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.
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Satisfaction of Healthy Subjects in Phase I TrialsSurvey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.
Latest:
Satisfaction of Healthy Subjects in Phase I TrialsSurvey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.
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Satisfaction of Healthy Subjects in Phase I TrialsSurvey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.
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Community Clinics as Trial Sites—Bridging the Gap Between Health Care and Clinical ResearchTurning community clinics into research sites requires provision of personnel, processes, technology, and infrastructure to conduct clinical research.
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CNS Drug Liabilities in Early Phase Clinical TrialsOnly eight percent of CNS drugs will reach approval, in part because of the high adverse effects standards.
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The IDEAS InitiativeImproving diversity, education, and advancement in studies: a look at the IDEAS initiative.
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The Changing Landscape of Cystic Fibrosis Clinical TrialsChanging demographics and evolving standards of care bring additional challenges when creating protocol designs.
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Improving Clinical Trial Enrollment Forecasts Using SORMA useful tool for clinical research professionals to estimate potential recruitment duration.
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Draft NIH Policy on the Use of a Single IRB for Multi-Site ResearchAt a time of the year when love is in the air, one thing is for sure: there is not a lot of love from the human research community on NIH’s Policy on the Use of a Single IRB for Multi-Site Research.
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Increased Data Transparency Unveils Terminology in DisarraySubject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
