Supply Chain Planning For Clinical Trials
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Supply Chain Planning For Clinical Trials
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Author : Ryan Mills
language : en
Publisher: John Wiley & Sons
Release Date : 2024-08-13
Supply Chain Planning For Clinical Trials written by Ryan Mills and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-08-13 with Science categories.
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.
Supply Chain Management In The Drug Industry
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Author : Hedley Rees
language : en
Publisher: John Wiley & Sons
Release Date : 2011-04-06
Supply Chain Management In The Drug Industry written by Hedley Rees and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-06 with Medical categories.
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.
Supply Chain Planning For Clinical Trials
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Author : Ryan Mills
language : en
Publisher: John Wiley & Sons
Release Date : 2024-07-03
Supply Chain Planning For Clinical Trials written by Ryan Mills and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-03 with Science categories.
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.
Strategic Management Of The Health Care Supply Chain
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Author : Eugene Schneller
language : en
Publisher: John Wiley & Sons
Release Date : 2023-07-11
Strategic Management Of The Health Care Supply Chain written by Eugene Schneller and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-07-11 with Medical categories.
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.
Patient Focused Network Integration In Biopharma
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Author : Robert Handfield
language : en
Publisher: CRC Press
Release Date : 2018-10-08
Patient Focused Network Integration In Biopharma written by Robert Handfield and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-08 with Business & Economics categories.
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.
Strategic Management Of The Health Care Supply Chain
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Author : Eugene S. Schneller
language : en
Publisher: Jossey-Bass
Release Date : 2006-02-17
Strategic Management Of The Health Care Supply Chain written by Eugene S. Schneller and has been published by Jossey-Bass this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-02-17 with Business & Economics categories.
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
Biopharmaceutical Supply Chains
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Author : Robert Handfield
language : en
Publisher: CRC Press
Release Date : 2012-06-06
Biopharmaceutical Supply Chains written by Robert Handfield and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-06 with Business & Economics categories.
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
Research Methods For Operations And Supply Chain Management
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Author : Christer Karlsson
language : en
Publisher: Taylor & Francis
Release Date : 2023-11-15
Research Methods For Operations And Supply Chain Management written by Christer Karlsson and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-15 with Business & Economics categories.
Research Methods for Operations and Supply Chain Management, third edition, is a toolkit of research approaches primarily for advanced students and beginner researchers, but also a reference book for any researcher in operations and supply chain management (OSCM). Many students begin their careers in research limited by the one or few approaches taken by their department. The concise, accessible overviews found here equip them with an understanding of a variety of methods and how to use them, enabling students to tailor their research project to their own strengths and goals. The more seasoned researcher will find comprehensive descriptions and analyses on a wide variety of research approaches. This updated and enhanced edition responds to the latest developments in OSCM, including the growing prominence of services and production of intangible products, the complete supply chain, and the increasing use of secondary data and of mixed approaches. Alternative research approaches are included and explored to help with the planning of research. This edition also includes expanded literature reviews and analysis to guide students towards the next steps in their reading, and more detailed step-by-step advice to tie theory with the research. Including contributions from an impressive range of the field’s leading thinkers in OSCM research, this is a guide that no one embarking on an OSCM research project should be without. Previous editions of this book were published under the title Research Methods for Operations Management and Researching Operations Management.
Practical Considerations For Adaptive Trial Design And Implementation
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Author : Weili He
language : en
Publisher: Springer
Release Date : 2014-10-15
Practical Considerations For Adaptive Trial Design And Implementation written by Weili He and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-15 with Medical categories.
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.
A Practical Guide To Quality Management In Clinical Trial Research
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Author : Graham Ogg
language : en
Publisher: CRC Press
Release Date : 2005-11-01
A Practical Guide To Quality Management In Clinical Trial Research written by Graham Ogg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-01 with Medical categories.
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.