Re Engineering Clinical Trials
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Re Engineering Clinical Trials
Author | : Peter Schueler,Brendan Buckley |
Publsiher | : Academic Press |
Total Pages | : 360 |
Release | : 2014-12-16 |
Genre | : Medical |
ISBN | : 9780128007907 |
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The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more
Innovation in Clinical Trial Methodologies
Author | : Peter Schueler |
Publsiher | : Academic Press |
Total Pages | : 202 |
Release | : 2020-11-01 |
Genre | : Medical |
ISBN | : 9780323860062 |
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Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials
Clinical Data Management
Author | : Richard K. Rondel,Sheila A. Varley,Colin F. Webb |
Publsiher | : John Wiley & Sons |
Total Pages | : 386 |
Release | : 2000-02-03 |
Genre | : Medical |
ISBN | : 0471983292 |
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Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2006
Author | : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies |
Publsiher | : Unknown |
Total Pages | : 2228 |
Release | : 2005 |
Genre | : United States |
ISBN | : STANFORD:36105050395925 |
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Clinical Trials
Author | : Tom Brody |
Publsiher | : Academic Press |
Total Pages | : 897 |
Release | : 2016-02-19 |
Genre | : Medical |
ISBN | : 9780128042588 |
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Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2005
Author | : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies |
Publsiher | : Unknown |
Total Pages | : 1890 |
Release | : 2004 |
Genre | : United States |
ISBN | : MINN:31951D02570187S |
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Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2004
Author | : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies |
Publsiher | : Unknown |
Total Pages | : 732 |
Release | : 2003 |
Genre | : United States |
ISBN | : LOC:00113683235 |
Download Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2004 Book in PDF, Epub and Kindle