Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE ...
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Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting clinical trials.
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Add this copy of Clinical Trial Project Management to cart. $202.19, new condition, Sold by Booksplease rated 4.0 out of 5 stars, ships from Southport, MERSEYSIDE, UNITED KINGDOM, published 2023 by Academic Press.
Add this copy of Clinical Trial Project Management to cart. $220.86, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2023 by Academic Press.
