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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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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.
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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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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.
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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.
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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.
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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.
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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.
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The Remote Patient-Centered Approach in Clinical ResearchIn the healthcare arena, the concept of patient-centeredness has expanded over the last 50 years, beginning as a term to describe patient engagement in self-health management and evolving to include various aspects of patient engagement in healthcare research.1
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Risking it All? Going All in on RBM AdoptionCancer Research UK (CRUK) followed such advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.
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Key Strategies in Sustaining the Investigator PoolThe sharp rise in ongoing clinical research studies is driving demand for greater participation in research by physicians as well as by patients.1
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Integrated Clinical Research Systems: A Chance to ReinventThe organization of healthcare is changing rapidly. The healthcare delivery system is increasingly powered by payers and regulators, and this directs both clinical medicine and drug development. Partly because of this change, the drug development process has been heavily scrutinized, and a great emphasis has been placed on more efficient translation of basic science into useful medicines.
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2020 Vision: Fulfilling the Future of Clinical ResearchIntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.
Latest:
2020 Vision: Fulfilling the Future of Clinical ResearchIntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.
