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A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
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A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
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Predictions for 2015: Trends in Clinical Trial ProcessesIt’s clear that the value clinical trials bring to the health and well being of our existence is being recognized and expectations from the public are high.
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Transforming Cognitive Health Conditions through Clinical GamesAs clinical games emerge as a new tool for diagnosing and treating cognitive health, it is important to understand how these tools work and the ways in which these tools are validated, as well as how to realize their full potential.
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The Employee Profile in China Pharma R&DIn this analysis, distinctions between who hires who in non-Chinese and China-based companies emerges.
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Keys to a Successful Study Start-up Transformation - Best Practices from Top 20 PharmasAutomating study start-up in a single application enables faster site activation, better collaboration with study partners, and more informed decision-making. Read this white paper to learn best practices from top 20 pharmas on effective study start-up deployment and how to overcome common barriers to change.
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Steps for a Successful Clinical Trial Management SystemAs the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.
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Positive Changes for Clinical Trials in UkraineThe Ukrainian Government has implemented several important measures to make the country more attractive for clinical trials.
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The Impact of Faster Drug Approvals on Oncology Clinical Trial DesignDue to a shifting landscape because of faster drug approvals, this article offers strategies for sponsors to design clinical trials.
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Using Compliance Data for Strategic AdvantageHelp desk centers offer sponsors the chance to mine valuable PV data.
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Big Data is Built From Tiny FragmentsDo patients really want to share their data? Nearly half of the rare disease patients responding to an international survey, are against their data being shared outside or even within the medical field.
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Designing Alzheimer’s Disease Clinical Trials For SuccessAlzheimer’s disease (AD) is and will remain one of the most unyielding public health crises of the 21st century. Aging global populations translate to a constantly growing prevalence of a disease with no cure and an immense cost of care. In the United States alone, recent estimates1 suggest that 28 million people will develop AD by midcentury. Approximately 25% of the annual Medicare budget will be spent treating the disease – a projected $330B in 2040 – with hundreds of billions more in indirect costs.
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Improving Oncology Trials Through Adaptive DesignsHow the practical application of these methods can help overcome the complex demands of cancer trials.
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Improving Oncology Trials Through Adaptive DesignsHow the practical application of these methods can help overcome the complex demands of cancer trials.
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Improving Oncology Trials Through Adaptive DesignsHow the practical application of these methods can help overcome the complex demands of cancer trials.
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Patient Recruitment FeasibilityDefining clinical trial feasibility and establishing a formula for patient recruitment success.
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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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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.
