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| clinical trial supply chain management: Supply Chain Planning for Clinical Trials Ryan Mills, 2024-07-03 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. |
| clinical trial supply chain management: Supply Chain Management in the Drug Industry Hedley Rees, 2011-04-06 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. |
| clinical trial supply chain management: Supply Chain Planning for Clinical Trials Ryan Mills, 2024-08-13 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. |
| clinical trial supply chain management: Oxford Handbook of Clinical and Healthcare Research Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, 2016 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. |
| clinical trial supply chain management: Clinical Trials Handbook Shayne Cox Gad, 2009-06-17 Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development. |
| clinical trial supply chain management: 20th European Symposium of Computer Aided Process Engineering Sauro Pierucci, G. Buzzi Ferraris, 2010-06-03 ESCAPE-20 is the most recent in a series of conferences that serves as a forum for engineers, scientists, researchers, managers and students from academia and industry to present and discuss progress being made in the area of Computer Aided Process Engineering (CAPE). CAPE covers computer-aided methods, algorithms and techniques related to process and product engineering. The ESCAPE-20 scientific program reflects the strategic objectives of the CAPE Working Party: to check the status of historically consolidated topics by means of their industrial application and to evaluate their emerging issues. - Includes a CD that contains all research papers and contributions - Features a truly international scope, with guest speakers and keynote talks from leaders in science and industry - Presents papers covering the latest research, key topical areas, and developments in computer-aided process engineering (CAPE) |
| clinical trial supply chain management: Managing Projects in Research and Development Ron Basu, 2016-03-09 Research and Development is the vehicle by which organizations and economies create opportunity, innovation and secure a stream of future products and services.These outcomes are all critically important sources of sustainability in a world that is changing faster than most companies can keep up.The challenge behind them is the fundamental unpredictability of R&D; which is why effective project management is so important. Ron Basu's Managing Projects in Research and Development explains how and why project management can provide a means of helping to plan, organise and control multi-disciplinary research activities without stifling innovation. Combining research with practical examples and experience from a career that has included blue chip organizations such as GSK, GlaxoWellcome and Unilever, Ron Basu offers a rigorous guide to the fundamentals of R&D project management including project lifecycle management, risk management, cost, time quality and other success measures as well as the keys to operational excellence in this complicated world. |
| clinical trial supply chain management: Introduction to Quality by Design (QbD) N. K. Jain, |
| clinical trial supply chain management: Practical Considerations for Adaptive Trial Design and Implementation Weili He, José Pinheiro, Olga M. Kuznetsova, 2014-10-15 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. |
| clinical trial supply chain management: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference. |
| clinical trial supply chain management: Issues in Chemical Engineering and other Chemistry Specialties: 2013 Edition , 2013-05-01 Issues in Chemical Engineering and other Chemistry Specialties: 2013 Edition is a ScholarlyEditions™ book that delivers timely, authoritative, and comprehensive information about Chemical Modeling. The editors have built Issues in Chemical Engineering and other Chemistry Specialties: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Chemical Modeling in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Chemical Engineering and other Chemistry Specialties: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/. |
| clinical trial supply chain management: Clinical Trials Duolao Wang, Ameet Bakhai, 2006 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. |
| clinical trial supply chain management: Patient-Focused Network Integration in BioPharma Robert Handfield, 2018-10-08 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. |
| clinical trial supply chain management: Clinical Trials in Neurology Bernard Ravina, Michael McDermott, 2012-04-12 Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences. |
| clinical trial supply chain management: Advances in Production Management Systems. Artificial Intelligence for Sustainable and Resilient Production Systems Alexandre Dolgui, Alain Bernard, David Lemoine, Gregor von Cieminski, David Romero, 2021-09-01 The five-volume set IFIP AICT 630, 631, 632, 633, and 634 constitutes the refereed proceedings of the International IFIP WG 5.7 Conference on Advances in Production Management Systems, APMS 2021, held in Nantes, France, in September 2021.* The 378 papers presented were carefully reviewed and selected from 529 submissions. They discuss artificial intelligence techniques, decision aid and new and renewed paradigms for sustainable and resilient production systems at four-wall factory and value chain levels. The papers are organized in the following topical sections: Part I: artificial intelligence based optimization techniques for demand-driven manufacturing; hybrid approaches for production planning and scheduling; intelligent systems for manufacturing planning and control in the industry 4.0; learning and robust decision support systems for agile manufacturing environments; low-code and model-driven engineering for production system; meta-heuristics and optimization techniques for energy-oriented manufacturing systems; metaheuristics for production systems; modern analytics and new AI-based smart techniques for replenishment and production planning under uncertainty; system identification for manufacturing control applications; and the future of lean thinking and practice Part II: digital transformation of SME manufacturers: the crucial role of standard; digital transformations towards supply chain resiliency; engineering of smart-product-service-systems of the future; lean and Six Sigma in services healthcare; new trends and challenges in reconfigurable, flexible or agile production system; production management in food supply chains; and sustainability in production planning and lot-sizing Part III: autonomous robots in delivery logistics; digital transformation approaches in production management; finance-driven supply chain; gastronomic service system design; modern scheduling and applications in industry 4.0; recent advances in sustainable manufacturing; regular session: green production and circularity concepts; regular session: improvement models and methods for green and innovative systems; regular session: supply chain and routing management; regular session: robotics and human aspects; regular session: classification and data management methods; smart supply chain and production in society 5.0 era; and supply chain risk management under coronavirus Part IV: AI for resilience in global supply chain networks in the context of pandemic disruptions; blockchain in the operations and supply chain management; data-based services as key enablers for smart products, manufacturing and assembly; data-driven methods for supply chain optimization; digital twins based on systems engineering and semantic modeling; digital twins in companies first developments and future challenges; human-centered artificial intelligence in smart manufacturing for the operator 4.0; operations management in engineer-to-order manufacturing; product and asset life cycle management for smart and sustainable manufacturing systems; robotics technologies for control, smart manufacturing and logistics; serious games analytics: improving games and learning support; smart and sustainable production and supply chains; smart methods and techniques for sustainable supply chain management; the new digital lean manufacturing paradigm; and the role of emerging technologies in disaster relief operations: lessons from COVID-19 Part V: data-driven platforms and applications in production and logistics: digital twins and AI for sustainability; regular session: new approaches for routing problem solving; regular session: improvement of design and operation of manufacturing systems; regular session: crossdock and transportation issues; regular session: maintenance improvement and lifecycle management; regular session: additive manufacturing and mass customization; regular session: frameworks and conceptual modelling for systems and services efficiency; regular session: optimization of production and transportation systems; regular session: optimization of supply chain agility and reconfigurability; regular session: advanced modelling approaches; regular session: simulation and optimization of systems performances; regular session: AI-based approaches for quality and performance improvement of production systems; and regular session: risk and performance management of supply chains *The conference was held online. |
| clinical trial supply chain management: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. |
| clinical trial supply chain management: Clinical Trials Tom Brody, 2011-11-11 Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the study schema and related features of study design Offers a hands-on reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn |
| clinical trial supply chain management: Computer Applications in Pharmaceutical Research and Development Sean Ekins, 2006-06-30 A unique, holistic approach covering all functions and phases of pharmaceutical research and development While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening. By providing a comprehensive view, the book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process. Chapters are organized into the following sections: * Computers in pharmaceutical research and development: a general overview * Understanding diseases: mining complex systems for knowledge * Scientific information handling and enhancing productivity * Computers in drug discovery * Computers in preclinical development * Computers in development decision making, economics, and market analysis * Computers in clinical development * Future applications and future development Each chapter is written by one or more leading experts in the field and carefully edited to ensure a consistent structure and approach throughout the book. Figures are used extensively to illustrate complex concepts and multifaceted processes. References are provided in each chapter to enable readers to continue investigating a particular topic in depth. Finally, tables of software resources are provided in many of the chapters. This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics and ADMET, drug discovery, and technology development. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics. |
| clinical trial supply chain management: The Economics of Contracts Eric Brousseau, Jean-Michel Glachant, 2002-10-17 A 2002 survey of economics of contracts appealing to scholars in economics, management and law. |
| clinical trial supply chain management: T Bytes Platforms & Applications ITShades.com, 2020-12-02 This document brings together a set of latest data points and publicly available information relevant for Platforms & Applications Industry.We are very excited to share this content and believe that readers will benefit from this periodic publication immensely. |
| clinical trial supply chain management: Technological Advancement in Internet of Medical Things and Blockchain for Personalized Healthcare A Prasanth, Lakshmi D, Rajesh Kumar Dhanaraj, Balamurugan Balusamy, Sherimon P C, 2024-05-08 Technological Advancement in Internet of Medical Things and Blockchain for Personalized Healthcare presents an overview of the innovative concepts, technologies, and various biomedical applications of the Internet of Medical Things (IoMT). Features: • Provides insights into smart contracts, healthcare monitoring equipment, and the next generation of Internet of Things sensors to improve adherence to chronic disease management programs and patient health. • Discusses the IoMT for personalized healthcare, security, and privacy issues of the IoMT in the healthcare sector. • Elaborates on the opportunities and challenges of blockchain technology in the healthcare system. • Focuses on the convergence of the IoMT and blockchain for emerging personalized healthcare systems. • Presents techniques and methods to secure IoMT devices to protect them from cyberattacks. This book is primarily written for graduate students and academic researchers working in the fields of computer science and engineering, biomedical engineering, and electrical engineering. |
| clinical trial supply chain management: Fourth Congress on Intelligent Systems Sandeep Kumar, |
| clinical trial supply chain management: Industrial Engineering and Operations Management João Carlos Gonçalves dos Reis, Francisco Gaudêncio Mendonça Freires, Milton Vieira Junior, 2024-01-21 This proceedings volume gathers selected, blinded peer-reviewed contributions presented at the XXIX International Joint Conference on Industrial Engineering and Operations Management (IJCIEOM), held in Lisbon, Portugal, from June 28th to 30th, 2023. This volume focuses especially on the applications of Industrial Engineering and Operations Management for research and practice. It includes relevant information for academics since most of the chapters focus on real-world case studies and systematic reviews. It also provides valuable insights for professionals in the industrial sector by presenting solutions to complex industrial challenges. The 2023 iteration of the IJCIEOM conference had the theme Developing resilience in Industrial Engineering and Operations Management and aimed to analyze the resilience of supply chains in the post-COVID-19 era. The works published in this volume focus on how Digital Transformation (DX) and Artificial Intelligence (AI) have made the manufacturing and service industry more resistant to VUCA elements (i.e., volatile, uncertain, complex, and ambiguous). Regarding DX and AI, the research specifically focused on supply chain management, project management, and Industry 4.0. Other studies explore how industrial engineering incorporated innovative and technological concepts into service and product operations. Overall, this volume provides a valuable resource for researchers and practitioners alike as it presents numerous relevant contributions in identifying new challenges and opportunities for industrial engineering and operations management. This conference was sponsored by renowned international industry engineering associations, particularly the American Society for Engineering Management (ASEM), the Institute of Industrial & Systems Engineers (IISE), and the Asociación para el Desarrollo de la Ingeniería de Organización (ADINGOR). |
| clinical trial supply chain management: The Oxford Handbook of Supply Chain Management Thomas Y. Choi, Julie Juan Li, Dale S. Rogers, Tobias Schoenherr, Stephan M. Wagner, This handbook is currently in development, with individual articles publishing online in advance of print publication. At this time, we cannot add information about unpublished articles in this handbook, however the table of contents will continue to grow as additional articles pass through the review process and are added to the site. Please note that the online publication date for this handbook is the date that the first article in the title was published online. |
| clinical trial supply chain management: Handbook of Adaptive Designs in Pharmaceutical and Clinical Development Annpey Pong, Shein-Chung Chow, 2016-04-19 In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip |
| clinical trial supply chain management: Computational Intelligence and Blockchain in Biomedical and Health Informatics Pankaj Bhambri, Sita Rani, Muhammad Fahim, 2024-06-19 Advancements in computational intelligence, which encompasses artificial intelligence, machine learning, and data analytics, have revolutionized the way we process and analyze biomedical and health data. These techniques offer novel approaches to understanding complex biological systems, improving disease diagnosis, optimizing treatment plans, and enhancing patient outcomes. Computational Intelligence and Blockchain in Biomedical and Health Informatics introduces the role of computational intelligence and blockchain in the biomedical and health informatics fields and provides a framework and summary of the various methods. The book emphasizes the role of advanced computational techniques and offers demonstrative examples throughout. Techniques to analyze the impacts on the biomedical and health Informatics domains are discussed along with major challenges in deployment. Rounding out the book are highlights of the transformative potential of computational intelligence and blockchain in addressing critical issues in healthcare from disease diagnosis and personalized medicine to health data management and interoperability along with two case studies. This book is highly beneficial to educators, researchers, and anyone involved with health data. Features: • Introduces the role of computational intelligence and blockchain in the biomedical and health informatics fields. • Provides a framework and a summary of various computational intelligence and blockchain methods. • Emphasizes the role of advanced computational techniques and offers demonstrative examples throughout. • Techniques to analyze the impact on biomedical and health informatics are discussed along with major challenges in deployment. • Highlights the transformative potential of computational intelligence and blockchain in addressing critical issues in healthcare from disease diagnosis and personalized medicine to health data management and interoperability. |
| clinical trial supply chain management: Blockchain, IoT, and AI Technologies for Supply Chain Management Veena Grover, |
| clinical trial supply chain management: Cell and Gene Therapies Miguel-Angel Perales, Syed A. Abutalib, Catherine Bollard, 2018-11-27 In this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee. |
| clinical trial supply chain management: Countering the Problem of Falsified and Substandard Drugs Institute of Medicine, Board on Global Health, Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, 2013-06-20 The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines. |
| clinical trial supply chain management: Prospects of Blockchain Technology for Accelerating Scientific Advancement in Healthcare Borah, Malaya Dutta, Zhang, Peng, Deka, Ganesh Chandra, 2021-12-13 Health information about any patent is extremely critical. As there are many malicious users and misuses of health data, this information is not shared amongst health organizations due to security and privacy issues. Blockchain is being explored as a platform for securely exchanging healthcare data among the organizations in public domains, allowing doctors and practitioners to have access to more comprehensive health histories and in turn provide better care to patients. Prospects of Blockchain Technology for Accelerating Scientific Advancement in Healthcare disseminates the recent research findings on blockchain in healthcare and reviews current state-of-the-art blockchain applications in healthcare. This book also discusses various challenges faced by the healthcare community in securing healthcare data. Covering topics such as consensus mechanisms, smart healthcare systems, and supply chain management, it serves as an essential resource for healthcare professionals, computer scientists, information security professionals, data scientists, policymakers, researchers, and academicians. |
| clinical trial supply chain management: Critical Thinking in Clinical Research Felipe Fregni, Ben M. W. Illigens, 2018 Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties. |
| clinical trial supply chain management: Clinical Data Management Richard K. Rondel, Sheila A. Varley, Colin F. Webb, 2000-02-03 Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research. |
| clinical trial supply chain management: Economic Evaluation in Clinical Trials Henry A. Glick, Jalpa A. Doshi, Seema S. Sonnad, 2014-10-02 It is increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. This book provides a practical guide to the techniques and issues involved in conducting economic evaluation in ongoing clinical trials, supported with examples. |
| clinical trial supply chain management: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-11-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| clinical trial supply chain management: Find It File It Flog It Hedley Rees, 2017-12-14 WARNING! Your life may be at risk due to the greed and avarice of pharma companies who are putting dangerous drugs on the market, in spite of so-called government controls. The process of producing a drug that hits the shelves involves millions of dollars of wasted money. Who pays? You do. |
| clinical trial supply chain management: Process Systems Engineering for Pharmaceutical Manufacturing Ravendra Singh, Zhihong Yuan, 2018-03-16 Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. - Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes - Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products - Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing |
| clinical trial supply chain management: Statistical Issues in Drug Development Stephen S. Senn, 2008-02-28 Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component. |
| clinical trial supply chain management: Allocation of Staff , 1983 |
| clinical trial supply chain management: 50 Studies Every Intensivist Should Know Edward A. Bittner, 2018 This title presents key studies that have shaped the practice of critical care medicine. Selected using a rigorous methodology, the studies cover topics including: sedation and analgesia, resuscitation, shock, ARDS, nutrition, renal failure, trauma, infection, diabetes, and physical therapy |
| clinical trial supply chain management: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
