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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.
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.
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.
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.
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.
"This publication covers both strategic and operational level elements of logistics and supply chain research, providing a comprehensive overview of the field with particular attention to new technologies, digitization, and optimization as applied in the era of globalized business"--
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.
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.
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.
Praise For Strategic Supply Chain Management: "This book shows convincingly that a robust supply chain strategy is critical for business success in today's uncertain economic environment. Cohen and Roussel explain not only what makes for a good supply chain strategy but also how to put that strategy into practice." -- Jim Miller, VP, Worldwide Operations, Google "Strategic Supply Chain Management loudly and clearly makes the case that successful companies' supply chain strategies are closely aligned with their competitive differentiation and operating models. The book uses in-depth examples that bring these concepts to life and demonstrate that one size doesn't fit all. Anyone who thinks operations is just another corporate function needs to read this book." -- Manish Bhatia, SVP, Worldwide Operations, SanDisk "The advent of global marketplaces, heightened competition, accelerated pace of product innovation, and fast-changing customer preferences have increased the impact of the supply chain on company profitability and long-term success. But cultural challenges to successful supply chain design remain. Cohen and Roussel's book provides a platform for addressing these challenges and is recommended reading for chief executives, strategy professionals, and supply chain practitioners." -- Martin Roper, Chief Executive Officer and President, Boston Beer "The authors present a straightforward path for developing and deploying a global supply chain strategy that addresses the priorities of today's executive management teams." --Hau Lee, Thoma Professor of Operations, Information and Technology, Stanford Graduate School of Business The classic guide to supply chain strategy--re-created to help business leaders gain an advantage in today's volatile, globalized arena The global landscape has changed dramatically since the first edition of Strategic Supply Chain Management established itself as the authority on creating value and achieving competitive advantage from the supply chain. Shorter economic cycles, more-frequent natural disasters, higher costs in low-cost countries, more-restricted access to working capital, and greater focus on sustainability have made effective supply chain management much more challenging--and much more critical to the bottom line. This second edition is your answer to gaining a strategic advantage in the face of these challenges. Drawing on dozens of new company examples as well as cutting-edge benchmarking research, it shows you how to make your supply chains more agile, flexible, and resilient. With 80 easy-to-read tables and diagrams, this fully revised book explains how to: Develop a supply chain strategy that will help you realize your business goals Design a process architecture that maps out the activities of the end-to-end supply chain Create the most effective supply chain organization Build the most beneficial relationships with your supply chain partners Use metrics to assess and drive business success Implement transformational change See how today's best supply chain strategies work in all-new profiles of BASF, Essilor, Haier, Kaiser Permanente, Lenovo, and Schlumberger. Find out what these industry leaders are doing to get the greatest value out of their supply chains. When value depends on how well you deliver, you need Strategic Supply Chain Management, Second Edition.