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Getting it Wrong: Are We Missing the Most Critical Point When it Comes to Achieving Clinical Trial Diversity?There is a growing need to refocus efforts on how diversity is achieved in clinical trials, because some are doing it wrong despite their best intentions.
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Precedents for Good Storage PracticeEffective strategies for ensuring the long-term integrity of specialized biological samples
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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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Cleaning Up Pharma's ReputationRight now the industry has a chance to reclaim its good name and recapture the public's respect for the power of what it can do.
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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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Maximizing Oncology Imaging DataIncreasing development costs and high failure rates require earlier integration of imaging data in the Phase I setting.
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Drug Development on Rails: Part TwoUsing a template both accelerates a project's timeline and infuses it with best practices.
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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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Example of an Industry-CRO PartnershipTarget Health and Infacare used a CRF database to answer all of FDA's questions.
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Using Pragmatic Randomization in Real-World StudiesHow pragmatic clinical trials increase the robustness of real world studies at a fraction of the cost of classical randomized controlled clinical trials.
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Sentiment Analysis: Understand Your Healthcare CustomersSentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.
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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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Are Clinical Trial Data Shared by the EMA Under Policy 0070 Really Public Data?The general assumption that the Policy 0070 data releases were public data releases can be challenged since there is a mechanism to enforce the ToU, and this mechanism will continue to exist after the Agency moves to the Netherlands.
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Developing and Validating Electronic DiariesThe study protocol and a set of specifications are the road map for developing the software and the support structures for an EPD study.
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Clinical Trial Shipping: The EssentialsWhat you need to know to save the bottom line...and your sanity.
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The Central Laboratory: 20 Years of EvolutionA detailed history of the billion-dollar industry since its inception in 1986 and what the future may hold.
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Achieving End-to-End Traceability Using Trace-XMLTraceability plays a crucial role in ensuring the integrity of source data and in reinforcing clinical research results. CDISC has developed Trace-XML as an extension of its Define-XML model for delivering clinical data lifestyle traceability from data collection through to final analysis.
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Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - FutureA follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
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ePROs: Practical Issues in Pen and Touchscreen SystemsA number of factors influence the successful electronic collection of patient data, including screen size.
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Clinical Trial Industry PredictionsMore access to trials, an increase in digitalization, and much more are on the horizon for the industry in 2021.
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What's Behind Clinical Trial Data?Jane Barrett discusses data quality as she addresses the question raised by DIA's 2nd European Clinical Forum: Is 90% of data rubbish?
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To BYOD or Not to BYOD? That's the ePRO Question...In the world of electronic patient reported outcomes, many clinical trial sponsors are interested in the concept of Bring Your Own Device...
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Reconsidering Third-Party Companies for Subject EnrollmentCentral call centers can relieve sites of tedious scheduling and record keeping, freeing them to focus on physical exams and other core tasks.
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Science in Recruitment Means a Greater ROISystemized knowledge: experience, insight, and predictive modeling deliver successful enrollment.
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Faint Hopes of Dispelling the Fog Around Cross-Border Trials in EuropeA forum of prominent industry stakeholders highlights the challenges for patients in navigating the multiple legal, regulatory, and ethical barriers to cross-border participation.
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Simulation: A Critical Tool in AdaptiveHow simulation can help in the planning and implementation of adaptive clinical trials.
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Saving LivesWhat do the G8 Summit, national security, and the pharmaceutical industry have in common?
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Hands-On Therapeutic TrainingOur training places heavy emphasis on site selection: The entire study may suffer if sites are chosen poorly.
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The Gatekeepers Are Gone: What’s Next for Digital Patient Engagement?The clinical trial industry has a rare opportunity to redefine its role in public health conversations.
