The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication ne...Lasīt vairāk
The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication ne...Lasīt vairāk
This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the ea...Lasīt vairāk
This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the ea...Lasīt vairāk
National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Board on Health Sciences Policy, Roundtable on Genomics and Precision Health, National Cancer Policy Fo
The workshop participants examine the current state of clinical trial data sharing and reuse and consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing--...Lasīt vairāk
Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, s...Lasīt vairāk
Fully updated and including new chapters on trial process and current industry and FDA guidelines, the third edition of this comprehensive guide to managing clinical trials provides a practical outline for designing robust systems for organizing and...Lasīt vairāk
The author provides, for pharmaceutical statisticians and researchers, an overview of ExpDesign Studio software for use in classical and adaptive designs of clinical trials. It covers different types of designs, from group sequential design to early-...Lasīt vairāk
(Izdošanas datums: 11-Jul-2008, Other digital carrier, Izdevniecība: Wiley-Blackwell, ISBN-13: 9780470368718)
ExpDesign Studio facilitates more efficient clinical trial design This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It...Lasīt vairāk
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Prokscha, who is a consultant and teaches at a University of California extension program, walks through each step in developing a data management plan for a clinical drug trial: designing the case report form and database, cleaning data, checking la...Lasīt vairāk
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1>Recent progress in high-throughput screening, combinatorial chemistry and molecular biology has radically changed the approach to drug discovery in the pharmaceutical industry. New challenges in synthesis result in new analytical methods. At presen...Lasīt vairāk
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Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems a...Lasīt vairāk
