Applied Clinical Trials
October 01, 2016
News
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FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.
October 01, 2016
View from Brussels
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New actions underway seek to find a consensus on the role of HTAs in the decision-making chain, including with clinical trials.
October 01, 2016
News
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The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.
October 01, 2016
News
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Survey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.
October 01, 2016
News
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Updated guidance incorporates the use of a patient-reported outcomes questionnaire-which could enable more endpoints and greater patient stratification for COPD trials.
October 01, 2016
News
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Q&A explores the evolution of community-based studies-and the related sample management, regulatory, compliance, and logistics support considerations.
October 01, 2016
A Closing Thought
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With cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.
October 01, 2016
Clinical Trial Insights
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New study finds that most biopharma companies are now using a standard set of key performance indicators.
October 01, 2016
Feature Article
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Study collects first comprehensive metrics on current supply management and distribution practices.
October 01, 2016
Feature Article
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An overview of clinical supply blinding methods in the context of the current research environment.
October 01, 2016
Feature Article
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From basic blood draws to more involved samples, keeping accurate track and records is crucial for trials.
October 01, 2016
Feature Article
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Using strategic planning to address hurdles in biosimilar development programs from the outset.
October 01, 2016
Issue PDF
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Click the title above to open the Applied Clinical Trials October/November 2016 issue in an interactive PDF format.