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Optimal COA Measurement Strategy in Modern Oncology TrialsExamining the two areas of weakness cited in FDA draft guidance.
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The DCT Network: When Experienced Providers Come Together, We Can Revolutionize Clinical ResearchPatients reap benefits of strong collaboration in executing DCTs.
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Genomes, Big Data and the Journey to Precision MedicineThis month marks a landmark in the quest for personalized medicine and the growing role of big data in health sciences – from clinical development through tracking patient outcomes long after a therapy has reached the market.
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Wearables: Where is Clinical Development Headed Next?The application of personal device technology in the health care space continues to evolve, fed by the development of health-related consumer products and services by segments of industry traditionally not focused on health
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Closing the Variance Gap: The Challenges with Clinical Trial Budget Management and ForecastingAs clinical trials continue to grow in complexity, tolerance for the growing variance between forecasted and actual clinical trial costs is shrinking.
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Placebo Effect of Transdermal NSAIDSThe implications and challenges of the placebo effect on regulatory agency product approval.
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Safety Considerations for Follow-On Non-Biologic Complex DrugsWith patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.
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Clinical Trial Recruitment in the Digital Era: Some Smart IdeasChallenging. Time-consuming. Expensive. Do words like these spring to mind when you contemplate the patient recruitment process for your clinical trials?
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Optimizing Clinical Trials Using Electronic Measurement and Analysis of Drug AdherenceDrug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority
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Machine Learning, Modeling, and Predictive Analytics: Key Principles for the Clinical ScientistWith the inherent limitations of traditional data sources, this overview explores the definitions and strategic fundamentals that inform machine learning and modeling techniques.
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Is There a Link Between Recruitment and Social Media?A survey of Belgian clinical research professionals offers insights into the future of social media
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Is There a Link Between Recruitment and Social Media?A survey of Belgian clinical research professionals offers insights into the future of social media
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The African Medicines Agency: Impacts on the Continent’s Clinical Trials RegulationHarmonization could turn the continent into an established site for clinical research and laboratories.
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Cloud Computing: Security in Clinical TrialsThere is a lot of buzz about “the cloud.” Formally known as cloud computing, the cloud relies on sharing of Information Technology (IT) resources.
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A Critical Piece of the Research Puzzle: How Metrics Have Transformed Clinical TrialsThree key insights about clinical trial advancements made possible by the advent of metrics
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Human Challenge Studies in Early Phase Antiviral DevelopmentThe concept of the human challenge model (HCM) originated from early societal attempts to halt the spread of acute diseases within their own communities
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The Eradication of False Signals in MonitoringHow optimizing RBQM risk detection reduces the efforts caused by false signals.
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Targeting eTMF for Efficiency and Productivity GainsIn clinical trials, the ability to effectively plan, collect and maintain essential clinical trial documentation is challenging.
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Expanding Data Management Services in ChinaEDC has become the data management platform of choice around the world, offering advantages such as increasing the quality and timely collection of data. Medrio, an EDC company that offers eClinical software solutions, has quoted that 70% of clinical trials are using EDC as a forms of collecting data in the United States. In China, we have seen adoption rates for EDC increase dramatically in recent years, fuelled by improved technology developments in mobile applications, and the increasing experience with EDC usage in clinical research.
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Millennials and their Impact on Clinical ResearchThe importance of examining this generation’s influence on the clinical trial value chain.
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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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Impact of Actigraphy in Clinical ResearchWith all the buzz around wearables, actigraphs-which monitor sleep and daytime activity levels-have been around for decades.
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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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Bridging the Gap for Better Patient EngagementA survey from the Avoca Group examines issues related to quality of clinical trials and trial participation from the patients' view.
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Considerations for Clinical Trial Design in Public Health EmergenciesWhile the fundamental concerns behind the design of most modern clinical trials are effectively the same, clinical trials that take place during public health emergencies face additional layers of challenges.
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Five Steps to Increase Site Satisfaction and Study SuccessOver the past three decades, clinical imaging has become an integral part of the drug development process for biopharmaceutical companies.
