Download or read book Supply Chain Planning for Clinical Trials written by Ryan Mills and published by John Wiley & Sons. This book was released on 2024-08-13 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: Tools for minimizing risk and expense by optimizing the relationship between supply and demand Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.
Download or read book Supply Chain Management in the Drug Industry written by Hedley Rees and published by John Wiley & Sons. This book was released on 2011-04-06 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
Download or read book Supply Chain Planning for Clinical Trials written by Ryan Mills and published by John Wiley & Sons. This book was released on 2024-07-03 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: Tools for minimizing risk and expense by optimizing the relationship between supply and demand Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Humanitarian Logistics written by R. Tomasini and published by Springer. This book was released on 2009-02-19 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Imagine planning an event like the Olympics. Now imagine planning the same event but not knowing when or where it will take place, or how many will attend. This is what humanitarian logisticians are up against. Oversights result in serious consequences for the victims of disasters. So they have to get it right, fast.
Download or read book Clinical Trials written by Duolao Wang and published by Remedica. This book was released on 2006 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Download or read book The Economics of Contracts written by Eric Brousseau and published by Cambridge University Press. This book was released on 2002-10-17 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 2002 survey of economics of contracts appealing to scholars in economics, management and law.
Download or read book Oxford Handbook of Clinical and Healthcare Research written by Sumantra Ray and published by Oxford University Press. This book was released on 2016 with total page 603 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
Download or read book Managing Supply Chain Risk written by ManMohan S. Sodhi and published by Springer Science & Business Media. This book was released on 2012-02-25 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Supply Chain Risk Management is an issue that many companies face and yet few companies know how to deal with it in a systematic and pragmatic manner. While avoiding and reducing supply chain risks are certainly preferable, developing ways to restore and stabilize supply chain operations rapidly after a major disruption is critical for managing global supply chains. Sodhi and Tang present important concepts, frameworks, strategies, and analyses that are essential for managing supply chain risks. Not only does this book suggest some practical ways to work with different partners to manage the risks that are present in a global supply chain, it creates a framework that would enable practitioners to engage researchers to work on this important area.” —Thomas A. Debrowski, Executive Vice President, Worldwide Operations, Mattel, Inc. “When a firm outsources its operations to external suppliers, the firm is vulnerable to major and rare disruptions that can occur at any link in the global supply chain. Because these disruptions rarely occur, few firms take commensurable actions to identify, assess, mitigate and respond to various types of supply chain risks. By introducing frameworks and concepts along with several case studies and a review of academic literature, Sodhi and Tang treat this important subject with practical relevance and academic rigor. This book will bring practitioners and researchers to develop effective and efficient ways to manage supply chain risks.” —Marshall L. Fisher, UPS Professor, Professor of Operations and Information Management and Co-Director of Fishman-Davidson Center for Service and Operations Management, The Wharton School, University of Pennsylvania “This book ties observations in practice to methodologies and research. The rich case examples motivated the approaches and methodologies used to mitigate risks, and in the course of doing so, Sodhi and Tang provided insights on existing and new research opportunities. As a result, this book is highly relevant to both practitioners and academics. Also, the book is also written with management lessons on how risks can be mitigated, and how risks can be contained once disruptions have occurred. As such, it is also a book for management to gain insights and to develop management skills.” —Hau L. Lee, Thoma Professor of Operations, Information and Technology and Director of the Stanford Global Supply Chain Management Forum, Graduate School of Business, Stanford University “As companies have extended their supply chains globally and as the face increasing resource issues, they face a number of new risk challenges. While there are various case studies written about supply chain risks, this book gives a comprehensive treatment of the subject with clarity. The concepts and frameworks developed by Sodhi and Tang in this book would create awareness of this important and yet not well understood subject, and strategies described in this book would stimulate practitioners to develop a holistic approach for identifying, assessing, mitigating, and responding to different types of supply chain risks.” —Nick Wildgoose, Global Supply Chain Proposition Manager, Zurich Insurance
Download or read book INFORMS Annual Meeting written by Institute for Operations Research and the Management Sciences. National Meeting and published by . This book was released on 2008 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Data Management written by Richard K. Rondel and published by John Wiley & Sons. This book was released on 2000-02-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Science Based Approaches to Respond to COVID and Other Public Health Threats written by Erick Guerrero and published by BoD – Books on Demand. This book was released on 2021-12-01 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: COVID-19 and other public health threats have contributed to more than six million deaths globally in a short amount of time. As such, there is an urgent need to respond to these threats in a way that improves global health and wellbeing. Written by a diverse group of exemplary scientists, the thirteen chapters in this volume provide unique, comprehensive, and science-based approaches to respond to macro-structural, human process, and micro issues affecting public health threats.
Download or read book CAPE written by L. Puigjaner and published by . This book was released on 2006 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Building a Better Delivery System written by Institute of Medicine and published by National Academies Press. This book was released on 2005-09-20 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a joint effort between the National Academy of Engineering and the Institute of Medicine, this books attempts to bridge the knowledge/awareness divide separating health care professionals from their potential partners in systems engineering and related disciplines. The goal of this partnership is to transform the U.S. health care sector from an underperforming conglomerate of independent entities (individual practitioners, small group practices, clinics, hospitals, pharmacies, community health centers et. al.) into a high performance "system" in which every participating unit recognizes its dependence and influence on every other unit. By providing both a framework and action plan for a systems approach to health care delivery based on a partnership between engineers and health care professionals, Building a Better Delivery System describes opportunities and challenges to harness the power of systems-engineering tools, information technologies and complementary knowledge in social sciences, cognitive sciences and business/management to advance the U.S. health care system.
Download or read book Adaptive Supply Chain Management written by Dmitry Ivanov and published by Springer Science & Business Media. This book was released on 2009-11-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adaptive Supply Chain Management develops new viewpoints on the SCM goal paradigm, problem semantics, and decision-making support. Drawing upon years of research and practical experience, and using numerous examples, the authors unite conceptual considerations of supply chains with a constructive level of engineering and solutions to real-world problems. Adaptive Supply Chain Management provides advanced insights into dynamics, complexity, and uncertainty in supply chains from the perspectives of systems analysis, control theory, and operations research. It also considers supply chain adaptability, stability, and crisis-resistance. Providing readers with a comprehensive view of advanced SCM concepts, constructive mathematical techniques and models, Adaptive Supply Chain Management is an invaluable text for practitioners and researchers who specialize in SCM and operations.
Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
