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Supply Chain Planning For Clinical Trials
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Book Synopsis Supply Chain Planning for Clinical Trials by : Ryan Mills
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.
Book Synopsis Remote Clinical Trials Operations by : Imane Ait Mbiriq
Download or read book Remote Clinical Trials Operations written by Imane Ait Mbiriq and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Remote clinical trials present the new approach of revolutionizing traditional clinical trials in order to decrease costs, accelerate the processes and improve the experience for participants and trial's staff. The Covid-19 pandemic has significantly encouraged the implementation of remote clinical trials, since it became harder to reach participants and patients. The Tufts Medical Center aims to adopt remote clinical trial practices for their future clinical trials. The future trials include (1) a phase 2b a clinical trial testing the effectiveness of niclosamide in the shortening the Covid-19 contagious period in children and adolescents and (2) a data collection trial with participants suffering from Long Covid symptoms. Although clinical trials can have different parameters and processes, this thesis suggests a general framework that can guide Tufts Medical center in their planning of the future remote trials including the design of the trial, the participant's recruiting, the trial's supplies' inventory management and the data collection during and at the end of the trial. The thesis also includes limitations and points of failure of the generalized framework.
Book Synopsis Supply Chain Management in the Drug Industry by : Hedley Rees
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.
Book Synopsis An Investigation of Clinical Trial Supply Chains by : Adam Fleischhacker
Download or read book An Investigation of Clinical Trial Supply Chains written by Adam Fleischhacker and published by . This book was released on 2009 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dissertation investigates production and inventory decisions made within clinical trial supply chains in order to reduce drug supply costs. By investigating the SEC filings of public companies, we find that drug supply costs frequently account for a significant portion of pharmaceutical companies' R & D spending. To unlock value tied up in clinical trial supply chains, three unique aspects of clinical trial supply chains are explored and associated supply chain decisions are optimized. The first unique factor that differentiates the supply chains for clinical trials is the risk of failure, meaning that the investigational drug is proven unsafe or ineffective during human testing. Upon failure, any unused inventory is essentially wasted and needs to be destroyed. We explore the effect of this failure on production planning decisions and find the planner's decision to be a balancing act between waste and destruction costs versus production inefficiency. To optimally achieve this balance, we generalize the Wagner-Whitin model to incorporate the risk of failure. A second unique aspect of clinical trials is that demand can go from being quite unpredictable to fully predictable during the course of a trial. To take advantage of this demand learning, intra-trial batches can be produced, but at the expense of scale economies. Using various learning curves, we study this balance between learning and economies of scale in a finite horizon inventory model with fixed production costs and two production options: the pre-trial batch and the intra-trial batch. We characterize the optimal policy for both production batches in regards to optimally scheduling and sizing production. Lastly, we analyze the distribution networks of global clinical trial supply chains. Unique to these networks is their temporary existence; trials are ceased after patient enrollment goals are met. To manage these networks, we present a new class of multi-echelon inventory models to make stock positioning decisions, develop algorithms to identify lower and upper bounds on the optimal objective function for this new class, and leverage those algorithms to provide insights into optimal supply chain configurations.
Book Synopsis Strategic Management of the Health Care Supply Chain by : Eugene Schneller
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.
Book Synopsis An Exploration of the Global Clinical Trial Ancillary Supply Chain and the Drivers of Success During the Pre, In, and Post Phases by : Joanne DeFusco Santomauro
Download or read book An Exploration of the Global Clinical Trial Ancillary Supply Chain and the Drivers of Success During the Pre, In, and Post Phases written by Joanne DeFusco Santomauro and published by . This book was released on 2019 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Until recently, academic and practitioner research on clinical trial supply chains focused on identifying innovative models and solutions in providing comparator and study drugs to global clinical sites. Due to the expansion of outsourcing efforts by pharmaceutical organizations, newly enacted global laws and regulations, and the continued push to increase the speed at which new drugs gain market approval, a new and extremely complex global "ancillary" supply chain has emerged. This manuscript focuses on the clinical trial ancillary supply chain: a supply chain that develops the end-to-end process resulting in the distribution and quality management of medical products and devices, consumable supplies, and patient giveaways to global clinical trial sites. Based on a series of quantitative analyses, this research assesses the influence of the customer, country, and product on the overall success of the supply chain. Three factors emerged from these analyses as having a direct influence on the clinical trial ancillary supply chain; product characteristics, magnitude (components of size), and stability (components of changes in scope). Part II of this research sought to understand the success of the supply chain by evaluating the moderating effects of knowledge management, organizational culture, therapeutic area, and type of shipment. Assessments of 444 customer and server surveys yielded components of a sense of shared culture, shared communication and transparency, and feeling educated and supported. Quantitative data analysis supported that these components had a moderating influence on success during the pre-trial phase of the supply chain. These research findings provide insight into the internal and external drivers of success within the complex and emergent clinical trial supply chain - a supply chain that helps pharmaceutical organizations bring innovative therapies to market and most important, those patients in need of such therapies to improve or even save their lives.
Book Synopsis Biopharmaceutical Supply Chains by : Robert Handfield
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
Book Synopsis Handbook of Research Methods for Supply Chain Management by : Childe, Stephen
Download or read book Handbook of Research Methods for Supply Chain Management written by Childe, Stephen and published by Edward Elgar Publishing. This book was released on 2022-10-18 with total page 551 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a panel of leading international researchers, this Handbook identifies the key topics for research in supply chain management using an innovative step-by-step approach and provides an extensive range of methodologies for researching the subjects.
Book Synopsis Patient-Focused Network Integration in BioPharma by : Robert Handfield
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.
Book Synopsis Positioning Inventory in Clinical Trial Supply Chains by : Adam Fleischhacker
Download or read book Positioning Inventory in Clinical Trial Supply Chains written by Adam Fleischhacker and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a result of slow patient recruitment and high patient costs in the United States, clinical trials are increasingly going global. While recruitment efforts benefit from a larger global footprint, the supply chain has to work harder at getting the right drug supply, to the right place, at the right time. Certain clinical trial supply chains, especially those supplying biologics, have a combination of unique attributes that have yet to be addressed by existing supply chain models. These attributes include a fixed patient horizon, an inflexible supply process, a unique set of service-level requirements, and an inability to transfer drug supplies among testing sites. In this paper, we provide a new class of multi-echelon inventory models to address these unique aspects. The resulting mathematical program is a nonlinear integer programming problem with chance constraints. Despite this complexity, we develop a solution method that transforms the original formulation into a linear integer equivalent. By analyzing special cases and through numerical study of both real-life and simulated examples, we develop novel insights into inventory positioning and the cost drivers in clinical trial supply chains.
Book Synopsis Project Management of Clinical Trials by : Richard Chamberlain
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.
Book Synopsis Supply Chain Planning by : Hans-Otto Günther
Download or read book Supply Chain Planning written by Hans-Otto Günther and published by Springer Science & Business Media. This book was released on 2009-03-05 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, supply chain planning has emerged as one of the most challenging problems in the industry. As a consequence, the planning focus is shifting from the management of plant-speci?c operations to a holistic view of the various logistics and productionstages, that is an approach in which suppliers, productionplants and customers are considered as constituents of an integrated network. A major dr- ing force behind this development lies in the globalization of the world economy, which has facilitated the co-operation between different partners working together in world-wide logistics networks. Hence, considerable cost savings can be gained from optimizing the structure and the operations of complex supply networks li- ing plants, suppliers, distribution centres and customers. Consequently, to improve the performance of the entire logistic chain, more sophisticated planning systems and more effective decision support are needed. Clearly, successful applications of supply chain management have driven the development of advanced planning systems (APS), which are concerned with s- porting decision-making activities at the strategic, tactical and operational decision level. These software packages basically rely on the application of quantitative methods, which are used to model the underlying complex decision problems c- sidering the limited availability of resources and the need to react on time to customer orders. The core module at the mid-term level of APS comprises op- ational supply chain planning. In many industries, productionstages are assigned to differentplantsand distribution centreshave been established at geographicallyd- persed locations.
Book Synopsis Clinical Trials in Neurology by : Bernard Ravina
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.
Book Synopsis Logistics and Supply Chain Management in the Globalized Business Era by : Lincoln C. Wood
Download or read book Logistics and Supply Chain Management in the Globalized Business Era written by Lincoln C. Wood and published by Business Science Reference. This book was released on 2021-10 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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"--
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
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.
Book Synopsis Research Methods for Operations and Supply Chain Management by : Christer Karlsson
Download or read book Research Methods for Operations and Supply Chain Management written by Christer Karlsson and published by Taylor & Francis. This book was released on 2023-11-15 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Advances in Integrated and Sustainable Supply Chain Planning by : José Miguel Laínez-Aguirre
Download or read book Advances in Integrated and Sustainable Supply Chain Planning written by José Miguel Laínez-Aguirre and published by Springer. This book was released on 2014-11-03 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decision making at the enterprise level often encompass not only production operations and product R&D, but other strategic functions such as financial planning and marketing. With the aim of maximizing growth and a firm’s value, companies often focus on co-ordinating these functional components as well as traditional hierarchical decision levels. Understanding this interplay can enhance enterprise capabilities of adaptation and response to uncertainties arising from internal processes as well as the external environment. This book presents concepts, methods, tools and solutions based on mathematical programming, which provides the quantitative support needed for integrated decision-making and ultimately for improving the allocation of overall corporate resources (e.g., materials, cash and personnel). Through a systems perspective, the integrated planning of the supply chain also promotes activities of reuse, reduction and recycling for achieving more sustainable environmental impacts of production/distribution networks. Thus, this book presents, for the first time, a unique integrated vision of the Enterprise Supply Chain Planning and provides a comprehensive account of the state of the art models, methods and tools available to address the above mentioned features of the modern supply chain. It offers a comprehensive review of the associated literature of supply chain management and then systematically builds on this knowledge base to develop the mathematical models representing each of the core functional units and decision levels of the corporation and shows how they can be integrated into a holistic decision problem formulation. Abundant illustrations and tables help maximize reader insights into the problems discussed with several case studies and industry application also examined. This book is intended as a textbook for academics (PhD, MSc), researchers and industry decision-makers, who are involved in the design, retrofit and evaluation of alternative scenarios for the improvement of the supply chain.
