The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Clinical Research in Paediatric Psychopharmacology: A Practical Guide is written and organized with the aim of being a practical guide, providing both an overview of clinical research in pediatric psychopharmacology and practical points to ... Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at ... Content Strategy 101 is an invaluable resource for transforming your technical content into a business asset. Found insideThis book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging ... "This new edition of a clear and succinct yet comprehensive guide to the field provides exactly the right introduction for those new to the challenges and the excitement of pharmacovigilance. Health Literacy: Prescription to End Confusion examines the body of knowledge that applies to the field of health literacy, and recommends actions to promote a health literate society. Found inside – Page 395Common Protocol Template The Common Protocol Template (CPT), developed by TransCelerate Biopharma Inc. in collaboration with stakeholders, is a harmonized ... Found insideNow in its fourth edition, Fraud and Misconduct in Biomedical Research boasts an impressive list of contributors from around the globe and introduces a new focus for the book, transforming it from a series of monographs into a publication ... A series of essays by a doctor who worked in a Philadelphia clinic reflects his concern about the poor state of medical care of impoverished urban families and the small triumphs he experienced as patients began to take control of their ... This book Asserts that the use of structured diagnostic interviews in clinical settings is justified, suggesting that it would be most cost-effective to target research assessment toward those groups most difficult to evaluate and most ... Found insideThis concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and ... Found inside – Page 1The only remaining issue is how to tap the enormous potential value buried in Code Halos. This book provides the model for doing just that. This is more than just a Big Data story. This is about the next era of business. This timely book for the primary care community offers a concise and easy to read guide for implementing an EMR system. In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among ... The art of Jin Shin, based on the Japanese healing art of energy medicine, is practiced throughout the world. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support ... Found insideMedical and Scientific Publishing will help fill the gap and help readers to: Understand processes of scientific and medical publishing Understand the role of an academic in medical publishing Become a better scientific communicator Develop ... This book walks you through the steps to crafting your Scientific Story for peer-review journals. This book demystifies the logical thinking required for hypothesis-driven research and encourages scientists to 'Drop the Mic'. Fundamentals of Clinical Practice, Second Edition presents medical students with a comprehensive guide to the social ramifications of a physician's work, and more experienced practitioners with the tools to augment their own patient ... Kennth Getz takes a fresh look at why participation in clinical research really matters. This book addresses what clinical participation means and how it helps to advance medical science. This practical text guides the reader in developing the necessary tools for teaching those patients with limited literacy skills. Like many other industries, health care is increasingly turning to digital information and the use of electronic resources. This two-volume set, consisting of LNCS 6608 and LNCS 6609, constitutes the thoroughly refereed proceedings of the 12th International Conference on Computer Linguistics and Intelligent Processing, held in Tokyo, Japan, in February 2011. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. This book is therefore of considerable interest to all students of biomedical informatics, from the newcomer to the professional informatician. Found inside – Page 5This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development ... Found insideAn essential book for all those clinicians and reserachers undertaking clinical trials. It will ensure that all involved in clinical trials undertake their investigation according to standard operating procedures. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent ... This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. Found insideThis handbook presents an overview of the phenomenon of reference - the ability to refer to and pick out entities - which is an essential part of human language and cognition. Found insideTo explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly ... A compact overview of the most relevant concepts and developments in International Management. The various strategy concepts of internationally active companies and their implementation in practice are the core of this book. Found inside... suggestions from Section 8.1.4 in the TransCelerate BioPharma Position Paper, ... their own risk threshold data sets by serving as an initial template, ... "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. 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