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 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 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 Strategic Management of the Health Care Supply Chain written by Eugene Schneller and published by John Wiley & Sons. This book was released on 2023-07-11 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: A systems approach to understanding the needs of today’s healthcare supply chain Strategic Management of the Healthcare Supply Chain offers a big-picture overview and a proven strategic framework for supply chain management in healthcare. It also addresses concrete strategies for risk management, partnerships, logistics, performance assessment, information technology, and beyond. Readers will gain a comprehensive understanding of the issues facing the healthcare supply chain and the opportunities that present themselves as we look toward the future. Written by a team of authors with both research expertise and practical experience in healthcare supply chain, this broad and impactful book teases out the complexities within the supply chain field and the healthcare ecosystem. The healthcare industry is evolving rapidly, and the role of the supply chain is shifting in response. Institutions and practitioners are collaborating more closely than ever with supply chain leaders. This shift introduces new opportunities and challenges at the level of healthcare delivery. Additionally, the role of supply chain in safeguarding the social determinants of health—food, transportation, critical health-related products—is rapidly expanding, especially in historically underserved populations. This revised edition takes a holistic approach to the needs of people and organizations, yielding strategies that will improve both economic and health outcomes. Gain the understanding you need to work toward building a mature supply chain organization Develop perspective on how the needs of the healthcare supply chain are shifting in the modern era Holistically assess supply chain performance and improve clinical, financial, and operational outcomes Identify opportunities to generate value, improve alliances, and cut costs This book will be of interest to graduate students in the health sector and supply chain programs, as well as working clinicians, health sector managers, and supply chain leaders. Policymakers looking to create a more resilient healthcare supply chain in the wake of COVID-19 will also find valuable insight inside.
Download or read book Biopharmaceutical Supply Chains written by Robert Handfield and published by CRC Press. This book was released on 2012-06-06 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain. Based
Download or read book Strategic Management of the Health Care Supply Chain written by Eugene S. Schneller and published by Jossey-Bass. This book was released on 2006-02-17 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic Management of the Health Care Supply Chain provides students, faculty, managers, and researchers with a clear understanding of the health care supply chain and its role in health care strategy. It builds on fundamental concepts including sourcing of materials, forecasting demand, selecting and employing distribution models, and assessing risks, showing how they aid in the pursuit of supply management excellence in the health sector. Strategic Management of the Health Care Supply Chain is filled with in-depth interviews with leaders in exemplary organizations and presents best practices in progressive supply chain management from many exemplary institutions. Praise for Strategic Management of the Health Care Supply Chain "Based on Schneller and Smeltzer's recent empirical research, and drawing on contemporary cases, this book presents compelling arguments for the value-added through effective supply chain performance and for repositioning the supply chain function to a strategic position within organizational structures." —Howard Zuckerman, senior advisor, Center for Health Management Research "This book reveals insights into possibilities for rapid, meaningful, and measurable improvements to the health care supply chain. It provides a futuristic view of the possibilities of the health care supply chain and provides workable solutions for improvement and market-based approaches for health care executives. This is a must read." —Mark McKenna, president, Novation
Download or read book Project Management of Clinical Trials written by Richard Chamberlain and published by Xlibris Corporation. This book was released on 2019-09-24 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Project Management of Clinical Trials describes how to apply project management principles to conduct clinical research studies. It describes the major deliverables from clinical research and then covers estimating dates, resources, and costs to produce those deliverables. Along with the book is a set of Excel spreadsheets that can be used to estimate the dates and costs to do different types of clinical trials.
Download or read book Patient Focused Network Integration in BioPharma written by Robert Handfield and published by CRC Press. This book was released on 2018-10-08 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry as we know it today is going through a massive upheaval as a result of the uncertainty of healthcare reform and increasing regulatory pricing pressure. A wake-up call to all sectors of the healthcare value chain, Patient-Focused Network Integration in BioPharma: Strategic Imperatives for the Years Ahead explores patient-focused network integration as quite possibly the only way for organizational evolution to occur. The book discusses how to align enterprises with the patient at the center. It details the historical context of the biopharmaceutical value chain and the current set of challenges facing the industry, and then details the author’s unique and sustainable agenda for change. The book traces the critical but often ignored relationships between hospitals, insurance companies, biopharma manufacturers, government regulators, and clinical scientists. For too long, these parties have been operating in a void, without recognizing the interconnectedness of their objectives, even though these objectives are often competing and misaligned. This book points out the gaps that exist and develops a set of recommendations regarding disease treatments, clinical development of new products, and collaboration between these players that can result in a sustainable solution to the healthcare mess. Each chapter can be viewed as an independent essay, in that it deals with a specific dimension of the healthcare value chain. However, together they provide an integrated discussion on how to begin the task of creating an integrated value chain network for healthcare. The book begins with the patient, and then works its way back down the value chain, all the way to the drug development and clinical trials stage of the value chain. The common thread throughout the chapters is the emphasis on collaboration, strategic alignment, and a focus on delivering value to the end patient. Very simply, all parties in the healthcare value chain network must align their strategic planning to derive innovation solutions. It is only through true collaboration and aligned thinking that the parties in the drug development, distribution, insurance payors, and hospital provider network can deal with the incredible complexity and massive challenges that face the industry. The book provides a compelling maturity model that enables readers to gauge the level of network integration their enterprise is at today, and where they need to move in the future.
Download or read book EClinical Trials written by Rebecca Daniels Kush and published by CenterWatch. This book was released on 2003 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Management of Clinical Trials written by Hesham Abdeldayem and published by BoD – Books on Demand. This book was released on 2018-06-06 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 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. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.
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 304 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 Supply Chain Planning written by Matthew J. Liberatore and published by Business Expert Press. This book was released on 2021-04-15 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: Through this book, practitioners will obtain valuable new insights and examples of implementable frameworks and methods for managing their supply chain functions and organizations. The critical role that supply chain planning contributes to a firm’s financial well-being has never been greater. All too often, however, considerable managerial resources are directed toward planning activities with minimal results. In this book, we present proven, practical management frameworks used by the authors to support supply chain operations management and planning in private industry. These frameworks provide methodologies for managing critical activities such as supply chain strategic planning and project selection, manufacturing and distribution planning, performance measurement, supply chain risk management, and customer logistics and inventory deployment. This book is intended for supply chain professionals, as well as for graduate and advanced undergraduate students. Practitioners will obtain valuable new insights and examples of implementable frameworks and methods for managing their supply chain functions and organizations. Students will develop an understanding of real-world approaches for supply chain planning, decision support, and many other key activities.
Download or read book Practical Considerations for Adaptive Trial Design and Implementation written by Weili He and published by Springer. This book was released on 2014-10-15 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
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 A Practical Guide to Quality Management in Clinical Trial Research written by Graham Ogg and published by CRC Press. This book was released on 2005-11-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.
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.
