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clinical trial supply management software: 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 management software: 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. |
clinical trial supply management software: 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 management software: Drug Discovery and Clinical Research SK Gupta, 2011-06 The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth. |
clinical trial supply management software: AI-Powered Productivity Dr. Asma Asfour, 2024-07-29 This book, AI-Powered Productivity, aims to provide a guide to understanding, utilizing AI and generative tools in various professional settings. The primary purpose of this book is to offer readers a deep dive into the concepts, tools, and practices that define the current AI landscape. From foundational principles to advanced applications, this book is structured to cater to both beginners and professionals looking to enhance their knowledge and skills in AI. This book is divided into nine chapters, each focusing on a specific aspect of AI and its practical applications: Chapter 1 introduces the basic concepts of AI, its impact on various sectors, and key factors driving its rapid advancement, along with an overview of generative AI tools. Chapter 2 delves into large language models like ChatGPT, Google Gemini, Claude, Microsoft's Turing NLG, and Facebook's BlenderBot, exploring their integration with multimodal technologies and their effects on professional productivity. Chapter 3 offers a practical guide to mastering LLM prompting and customization, including tutorials on crafting effective prompts and advanced techniques, as well as real-world examples of AI applications. Chapter 4 examines how AI can enhance individual productivity, focusing on professional and personal benefits, ethical use, and future trends. Chapter 5 addresses data-driven decision- making, covering data analysis techniques, AI in trend identification, consumer behavior analysis, strategic planning, and product development. Chapter 6 discusses strategic and ethical considerations of AI, including AI feasibility, tool selection, multimodal workflows, and best practices for ethical AI development and deployment. Chapter 7 highlights the role of AI in transforming training and professional development, covering structured training programs, continuous learning initiatives, and fostering a culture of innovation and experimentation. Chapter 8 provides a guide to successfully implementing AI in organizations, discussing team composition, collaborative approaches, iterative development processes, and strategic alignment for AI initiatives. Finally, Chapter 9 looks ahead to the future of work, preparing readers for the AI revolution by addressing training and education, career paths, common fears, and future trends in the workforce. The primary audience for the book is professionals seeking to enhance productivity and organizations or businesses. For professionals, the book targets individuals from various industries, reflecting its aim to reach a broad audience across different professional fields. It is designed for employees at all levels, offering valuable insights to both newcomers to AI and seasoned professionals. Covering a range of topics from foundational concepts to advanced applications, the book is particularly relevant for those interested in improving efficiency, with a strong emphasis on practical applications and productivity tools to optimize work processes. For organizations and businesses, the book serves as a valuable resource for decision-makers and managers, especially with chapters on data-driven decision-making, strategic considerations, and AI implementation. HR and training professionals will find the focus on AI in training and development beneficial for talent management, while IT and technology teams will appreciate the information on AI tools and concepts. |
clinical trial supply management software: Computer Aided Pharmaceutics and Drug Delivery Vikas Anand Saharan, 2022-05-30 This book examines the role of computer-assisted techniques for discovering, designing, optimizing and manufacturing new, effective, and safe pharmaceutical formulations and drug delivery systems. The book discusses computational approaches, statistical modeling and molecular modeling for the development and safe delivery of drugs in humans. The application of concepts of QbD (Quality by Design), DoE (Design of Experiments), artificial intelligence and in silico pharmacokinetic assessment/simulation have been made a lot easier with the help of commercial software and expert systems. This title provides in-depth knowledge of such useful software with illustrations from the latest researches. The book also fills in the gap between pharmaceutics and molecular modeling at micro, meso and maro scale by covering topics such as advancements in computer-aided Drug Design (CADD), drug-polymer interactions in drug delivery systems, molecular modeling of nanoparticles and pharmaceutics/bioinformatics. This book provides abundant applications of computers in formulation designing and characterization are provided as examples, case studies and illustrations. Short reviews of software, databases and expert systems have also been added to culminate the interest of readers for novel applications in formulation development and drug delivery. Computer-aided pharmaceutics and drug delivery is an authoritative reference source for all the latest scholarly update on emerging developments in computed assisted techniques for drug designing and development. The book is ideally designed for pharmacists, medical practitioners, students and researchers. |
clinical trial supply management software: 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 management software: OPERATIONS AND SUPPLY CHAIN MANAGEMENT Prof. (Dr.) Milind Audumbar Kulkarni, Mr. Hemant Vishwanath More, 2022-06-20 What is Operations management? Every business is managed through three major functions: finance, marketing, and operations management. Illustrates this by showing that the vice presidents of each of these functions report directly to the president or CEO of the company. Other business functions— such as accounting, purchasing, human resources, and engineering—support these three major functions. Finance is the function responsible for managing cash flow, current assets, and capital investments. Marketing is responsible for sales, generating customer demand, and understanding customer wants and needs. Most of us have some idea of what finance and marketing are about, but what does operations management do? Operations management (OM) is the business function that plans, organizes, coordi- nates, and controls the resources needed to produce a company’s goods and services. Operations management is a management function. It involves managing people, equipment, technology, information, and many other resources. Operations management is the central core function of every company. This is true whether the company is large or small, provides a physical good or a service, is for-profit or not-for-profit. Every company has an operations management function. Actually, all the other organizational functions are there primarily to support the operations function. Without operations, there would be no goods or services to sell. Consider a retailer such as The Gap, which sells casual apparel. The marketing function provides promotions for the merchandise, and the finance function provides the needed capital. It is the operations function, however, that plans and coordinates all the resources needed to design, produce, and deliver the merchandise to the various retail locations. Without operations, there would be no goods or services to sell to customers. |
clinical trial supply management software: Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods Sandeep Menon, Richard C. Zink, 2015-12-09 This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. -- |
clinical trial supply management software: Global Clinical Trials Playbook Menghis Bairu, Richard Chin, 2012-04-20 Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in neglected diseases and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios |
clinical trial supply management software: Management of Data in Clinical Trials Eleanor McFadden, 2007-12-14 A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of off-the-shelf solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels. |
clinical trial supply management software: 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 management software: 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 management software: Software Innovations in Clinical Drug Development and Safety Chakraborty, Partha, 2015-10-02 In light of the rising cost of healthcare and the overall challenges associated with delivering quality care to patients across regions, scientists and pharmacists are exploring new initiatives in drug discovery and design. One such initiative is the adoption of information technology and software applications to improve healthcare and pharmaceutical processes. Software Innovations in Clinical Drug Development and Safety is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing. Taking a multi-faceted approach to the application of computational methods to pharmaceutical science, this publication is ideal for healthcare professionals, pharmacists, computer scientists, researchers, and students seeking the latest information on the architecture and design of software in clinical settings, the impact of clinical technologies on business models, and the safety and privacy of patients and patient data. This timely resource features a well-rounded discussion on topics pertaining to the integration of computational methods in pharmaceutical science and practice including, the impact of software integration on business models, patient safety concerns, software architecture and design, and data security. |
clinical trial supply management software: 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 management software: Adaptive and Flexible Clinical Trials Richard Chin, 2016-04-19 Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistic |
clinical trial supply management software: Classification of digital interventions, services and applications in health World Health Organization, 2023-10-24 |
clinical trial supply management software: Hospital Supply Chain Fouad Jawab, |
clinical trial supply management software: 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 management software: 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 management software: Clinical trials in drug metabolism and transport: 2022 Yurong Lai, Stanislav Yanev, Zhihao Liu, 2023-11-02 |
clinical trial supply management software: Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS Richard C. Zink, 2014-07 International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. The analytical methods described enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing. |
clinical trial supply management software: 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 management software: Medical Informatics Kenneth R. Ong, William N. Kelly, 2015-03-27 This third edition of HIMSS' award-winning, bestseller explores how clinicians, patients, and health IT stakeholders are collaborating to support high-value care through health IT. Medical Informatics: An Executive Primer continues to explore information technologies applied in hospital settings, at the physician's office and in patients' homes to |
clinical trial supply management software: Clinical Laboratory Management Timothy C. Allen, Vickie S. Baselski, Deirdre L. Church, Donald S. Karcher, Michael R. Lewis, Andrea J. Linscott, Melinda D. Poulter, Gary W. Procop, Alice S. Weissfeld, Donna M. Wolk, 2024-03-25 Clinical Laboratory Management Apply the principles of management in a clinical setting with this vital guide Clinical Laboratory Management, Third Edition, edited by an esteemed team of professionals under the guidance of editor-in-chief Lynne S. Garcia, is a comprehensive and essential reference for managing the complexities of the modern clinical laboratory. This newly updated and reorganized edition addresses the fast-changing landscape of laboratory management, presenting both foundational insights and innovative strategies. Topics covered include: an introduction to the basics of clinical laboratory management, the regulatory landscape, and evolving practices in the modern healthcare environment the essence of managerial leadership, with insights into employee needs and motivation, effective communication, and personnel management, including the lack of qualified position applicants, burnout, and more financial management, budgeting, and strategic planning, including outreach up-to-date resources for laboratory coding, reimbursement, and compliance, reflecting current requirements, standards, and challenges benchmarking methods to define and measure success the importance of test utilization and clinical relevance future trends in pathology and laboratory science, including developments in test systems, human resources and workforce development, and future directions in laboratory instrumentation and information technology an entirely new section devoted to pandemic planning, collaboration, and response, lessons learned from COVID-19, and a look towards the future of laboratory preparedness This indispensable edition of Clinical Laboratory Management not only meets the needs of today’s clinical laboratories but anticipates the future, making it a must-have resource for laboratory professionals, managers, and students. Get your copy today, and equip yourself with the tools, strategies, and insights to excel in the complex and ever-changing world of the clinical laboratory. |
clinical trial supply management software: A Manager's Guide to the Design and Conduct of Clinical Trials Phillip I. Good, 2003-05-14 This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e-submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls |
clinical trial supply management software: Cobert's Manual of Drug Safety and Pharmacovigilance Barton Cobert, 2011-04-01 Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem. Important Notice: The digital edition of this book is missing some of the images or content found in the physical edition. |
clinical trial supply management software: Official Gazette of the United States Patent and Trademark Office , 2003 |
clinical trial supply management software: Biomedical Index to PHS-supported Research: pt. A. Subject access A-H , 1992 |
clinical trial supply management software: Plunkett's Biotech & Genetics Industry Almanac Jack W. Plunkett, 2008-09 A complete market research guide to the business of biotech, genetics, proteomics and related services--a tool for strategic planning, competitive intelligence, employment searches, or financial research. Complete profiles of nearly 400 leading biotech companies, in-depth chapters on trends. Includes glossary thorough indexes, statistics, research and development, emerging technology--as well a addresses, phone numbers, and executive names. |
clinical trial supply management software: Special Topics in Drug Discovery Taosheng Chen, Sergio Chai, 2016-11-30 Drug discovery involves multiple disciplines, technologies, and approaches. This book selects important topics related to drug discovery, including emerging tool (Chapter 1), cutting-edge approaches (Chapters 2, 3, and 4), examples of specific therapeutic area (Chapter 5), quality control in drug development (Chapter 6), and job and career opportunities in the pharmaceutical sector, a topic rarely covered by other books (Chapter 7). This book draws knowledge from experts actively involved in different areas of drug discovery from both industrial and academic settings. We hope that this book will facilitate your efforts in drug discovery. |
clinical trial supply management software: Artificial Intelligence and Industrial Applications Tawfik Masrour, Ibtissam El Hassani, Noureddine Barka, 2023-10-16 Amid the dynamic growth of artificial intelligence, this book presents a collection of findings and advancements from the second edition of the A2IA-Artificial Intelligence and Industrial Applications conference. The conference, hosted by ENSAM-Meknès at Moulay Ismail University, Morocco, fosters knowledge exchange in AI, focusing primarily on its industrial applications. Covering a wide range of topics, the book highlights the adaptable nature of AI and its increasing impact on industrial sectors. It brings together contributions from an international cohort of researchers, discussing themes such as intelligent manufacturing and maintenance, intelligent supply chain management, various modes of learning including supervised, unsupervised, reinforcement, semi-supervised, and graph-based, as well as neural networks, deep learning, planning, and optimization. A defining feature of this edition is its extensive scope and emphasis on the practical applications of AI, along with its foundational elements. It facilitates an understanding of AI's current state and potential future direction, showcasing recent developments that bridge the gap between theory and practice. Designed for a diverse readership, this book is of interest to AI practitioners, academics, and enthusiasts, as well as to those new to the field. It provides an opportunity to explore AI's critical role in industrial applications, and the practical insights it offers are likely to be beneficial for decision-making within industrial settings. |
clinical trial supply management software: A Practical Guide to Quality Management in Clinical Trial Research Graham Ogg, 2005-11-01 Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co |
clinical trial supply management software: Principles of Research Methodology Phyllis G. Supino, Jeffrey S. Borer, 2012-06-22 Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better. |
clinical trial supply management software: Managing Operations Throughout Global Supply Chains Essila, Jean C., 2019-06-14 Globalization has made both operations and supply chains more complex than ever before. Inputs are sourced from many locations all over the world to serve different needs and market segments throughout the planet, making it a global challenge that necessitates a global strategic response. Managing Operations Throughout Global Supply Chains is a crucial academic resource that discusses concepts, methodologies, and applications of emerging techniques for operations and supply chain management processes that promote cost efficiency. While highlighting topics such as global operations, resource planning, and business forecasting, this publication explores how organizations manage the procurement of all necessary resources at every stage of the production cycle from the original source to the final consumers. This book is ideally designed for researchers, academicians, practitioners, professional organizations, policymakers, and government officials. |
clinical trial supply management software: Computerworld , 2006-08-07 For more than 40 years, Computerworld has been the leading source of technology news and information for IT influencers worldwide. Computerworld's award-winning Web site (Computerworld.com), twice-monthly publication, focused conference series and custom research form the hub of the world's largest global IT media network. |
clinical trial supply management software: New Scientist , 2002 |
clinical trial supply management software: Conducting Clinical Trials Frank L. Iber, W. Anthony Riley, Patricia J. Murray, 2012-12-06 A few years ago, two of us joined our senior colleague at Pharma Kinetics Laboratories, a newly public contract research firm just under taking a major expansion into the clinical trials market. The company's unique concept of clinical research held great promise and had suc cessfully endured many of the fits and starts characteristic of entrepre neurial organizations. With a staff of highly enthusiastic, albeit inex perienced, field personnel located in 30-odd cities around the country, we found ourselves off and running with several critical research pro grams for major pharmaceutical manufacturers. Our excitement with the innovation was tempered with the reality of staffing and bearing responsibility for more than 30 field offices and 300 new staff persons, more than half of whom had no previous experience in the pharma ceutical industry. In the ensuing few years, we explored by trial and error many workable and unworkable patterns of training! delegation, data collec tion, and auditing. The ideas expressed in this book benefited greatly from that experience and from the willingness of our co-workers and clients to share insights and problems. During those years, we also sought guidance from the works available on the clinical trials field. Although we found numerous references on research ethics, little guid ance was available on the practical aspects of conducting a clinical trial. |
clinical trial supply management software: Advances in Software Engineering, Education, and e-Learning Hamid R. Arabnia, Leonidas Deligiannidis, Fernando G. Tinetti, Quoc-Nam Tran, 2021-09-09 This book presents the proceedings of four conferences: The 16th International Conference on Frontiers in Education: Computer Science and Computer Engineering + STEM (FECS'20), The 16th International Conference on Foundations of Computer Science (FCS'20), The 18th International Conference on Software Engineering Research and Practice (SERP'20), and The 19th International Conference on e-Learning, e-Business, Enterprise Information Systems, & e-Government (EEE'20). The conferences took place in Las Vegas, NV, USA, July 27-30, 2020 as part of the larger 2020 World Congress in Computer Science, Computer Engineering, & Applied Computing (CSCE'20), which features 20 major tracks. Authors include academics, researchers, professionals, and students. This book contains an open access chapter entitled, Advances in Software Engineering, Education, and e-Learning. Presents the proceedings of four conferences as part of the 2020 World Congress in Computer Science, Computer Engineering, & Applied Computing (CSCE'20); Includes the tracks Computer Engineering + STEM, Foundations of Computer Science, Software Engineering Research, and e-Learning, e-Business, Enterprise Information Systems, & e-Government; Features papers from FECS'20, FCS'20, SERP'20, EEE'20, including one open access chapter. |
clinical trial supply management software: The Textbook of Pharmaceutical Medicine John P. Griffin, John Posner, Geoffrey R. Barker, 2013-03-29 The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail |
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; unemotionally …
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.