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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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Recruiting Clinical Trial Participants: How to Balance Data and TrustUnderstanding how the dynamics between the two play hand in hand in influencing patient recruitment and retention.
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Personal Digital Assistance: Finding the Right PDA for the JobThree profiled companies have three different needs when it comes to choosing PDA.
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What Do We Know About Clinical Trials?I've recently reviewed many articles on subject recruitment, retention, and attrition in clinical trials. I have found the same three basic research methods: surveys (by telephone and in person), interviews, and focus groups. The information gathered from the three methods include demographics, willingness to participate, problems experienced in clinical trials, motivations for volunteering, health behaviors, social support, benefit expectations, and understanding of the research project. But such strategies collect only the most superficial data, so we don't know nearly as much about the clinical trial experience as we need to know.
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Clinical Research in Mexico: An OverviewThe United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
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Adaptive Patient Recruitment for 21st Century Clinical ResearchA key function in clinical trials, patient enrollment, has fallen behind during a time where technology has played a vital role in the industry. Adaptive patient recruitment allows for clinical data to be collected and reviewed in real-time as to improve enrollment outcomes as they are taking place.
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Good Site and Sponsor Relationships Pay OffBoth parties benefit from intentional friendships, and nowadays CRAs are key to this cordial effort.
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A Closer Look at 1572: Interpreting the FDA's Statement of Investigator FormA new reference guide clarifies uncertainty surrounding this sometimes misunderstood document.
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Some Things Work Better as PartnershipsPartnership agreements for CROs and eClinical technology providers can be as beneficial as sponsor/CRO partnerships.
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Progress and Potential: Evolution of the CRO IndustryThe CRO industry is on a course for continued rapid growth with the rise of genetics and genomics, as well as the push toward partnering and more postapproval research.
