Supply Chain Planning For Clinical Trials PDF Download
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Author | : Ryan Mills |
Publisher | : John Wiley & Sons |
Total Pages | : 501 |
Release | : 2024-07-03 |
Genre | : Science |
ISBN | : 139417957X |
Download Supply Chain Planning for Clinical Trials Book in PDF, ePub and Kindle
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.
Author | : Imane Ait Mbiriq |
Publisher | : |
Total Pages | : 0 |
Release | : 2022 |
Genre | : |
ISBN | : |
Download Remote Clinical Trials Operations Book in PDF, ePub and Kindle
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.
Author | : Hedley Rees |
Publisher | : John Wiley & Sons |
Total Pages | : 458 |
Release | : 2011-04-06 |
Genre | : Medical |
ISBN | : 0470922842 |
Download Supply Chain Management in the Drug Industry Book in PDF, ePub and Kindle
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.
Author | : Ryan Mills |
Publisher | : John Wiley & Sons |
Total Pages | : 501 |
Release | : 2024-08-13 |
Genre | : Science |
ISBN | : 1394179553 |
Download Supply Chain Planning for Clinical Trials Book in PDF, ePub and Kindle
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.
Author | : Adam Fleischhacker |
Publisher | : |
Total Pages | : 106 |
Release | : 2009 |
Genre | : Clinical pharmacology |
ISBN | : |
Download An Investigation of Clinical Trial Supply Chains Book in PDF, ePub and Kindle
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.
Author | : Eugene Schneller |
Publisher | : John Wiley & Sons |
Total Pages | : 390 |
Release | : 2023-07-11 |
Genre | : Medical |
ISBN | : 1119908612 |
Download Strategic Management of the Health Care Supply Chain Book in PDF, ePub and Kindle
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.
Author | : Joanne DeFusco Santomauro |
Publisher | : |
Total Pages | : 124 |
Release | : 2019 |
Genre | : |
ISBN | : |
Download An Exploration of the Global Clinical Trial Ancillary Supply Chain and the Drivers of Success During the Pre, In, and Post Phases Book in PDF, ePub and Kindle
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.
Author | : Robert Handfield |
Publisher | : CRC Press |
Total Pages | : 275 |
Release | : 2012-06-06 |
Genre | : Business & Economics |
ISBN | : 1466568046 |
Download Biopharmaceutical Supply Chains Book in PDF, ePub and Kindle
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
Author | : Childe, Stephen |
Publisher | : Edward Elgar Publishing |
Total Pages | : 551 |
Release | : 2022-10-18 |
Genre | : Business & Economics |
ISBN | : 1788975863 |
Download Handbook of Research Methods for Supply Chain Management Book in PDF, ePub and Kindle
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.
Author | : Bernard Ravina |
Publisher | : Cambridge University Press |
Total Pages | : 387 |
Release | : 2012-04-12 |
Genre | : Medical |
ISBN | : 1107376572 |
Download Clinical Trials in Neurology Book in PDF, ePub and Kindle
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.