Global Clinical Trials Playbook

Author: Menghis Bairu
Publisher: Academic Press
ISBN: 0124157874
Size: 60.13 MB
Format: PDF, Mobi
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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

Global Clinical Trials

Author: Richard Chin
Publisher: Academic Press
ISBN: 9780123815385
Size: 58.35 MB
Format: PDF, ePub
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This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

Global Clinical Trials For Alzheimer S Disease

Author: Menghis Bairu
Publisher: Academic Press
ISBN: 0124115306
Size: 52.84 MB
Format: PDF, ePub, Mobi
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Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

The Climate Change Playbook

Author: Dennis Meadows
Publisher: Chelsea Green Publishing
ISBN: 1603586768
Size: 37.69 MB
Format: PDF
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Advocates and teachers often find it difficult to communicate the complexities of climate change, because the people they are trying to reach hold so many mistaken assumptions. They assume, for example, that when climate change becomes an obvious threat to our everyday lives, there will still be time enough to make changes that will avoid disaster. Yet at that point it will be too late. Or they assume we can use our current paradigms and policy tools to find solutions. Yet the approaches that caused damage in the first place will cause even more damage in the future. Even the increasingly dire warnings from scientists haven’t shaken such assumptions. Is there another way to reach people? The simple, interactive exercises in The Climate Change Playbook can help citizens better understand climate change, diagnose its causes, anticipate its future consequences, and effect constructive change. Adapted from The Systems Thinking Playbook, the twenty-two games are now specifically relevant to climate-change communications and crafted for use by experts, advocates, and educators. Illustrated guidelines walk leaders through setting each game up, facilitating it, and debriefing participants. Users will find games that are suitable for a variety of audiences—whether large and seated, as in a conference room, or smaller and mobile, as in a workshop, seminar, or meeting. Designed by leading thinkers in systems, communications, and sustainability, the games focus on learning by doing.

The Public Innovator S Playbook

Author: William D. Eggers
Publisher:
ISBN: 9780979061110
Size: 49.22 MB
Format: PDF
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"Describes, using real-world examples, how a public sector organization can go from a culture of 'innovation by accident' to one in which a sustained organizational commitment to innovation is baked into the organization's DNA." - page 5.

Flex

Author: Jane Hyun
Publisher: Harper Collins
ISBN: 0062248537
Size: 37.74 MB
Format: PDF, ePub, Docs
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Renowned executive coaches and global leadership strategists Jane Hyun and Audrey S. Lee offer lessons on the vital skill of “Flexing”—the art of switching leadership styles to more effectively lead people who are different from you, allowing managers to successfully manage the multicultural workers of today and tomorrow. Flex offers a proactive strategy for managers to navigate and leverage diversity effectively in this new global economy, showing managers how to: understand the power gap, the social distance between you and those in the workplace of different cultures, ages, and gender; flex your management style, by stretching how you work and communicate with others, and bridging the gap with more effective communication, feedback tools and building healthy teams; and multiply the effect, by teaching these skills to others and closing the power gap with clients, customers, and partners to create innovative solutions. Creating flex in a company’s management style will impact all aspects of developing the talent you have, attracting future talent and building relationships with customers in this competitive marketplace. Now, Flex: The New Playbook for Managing Across Differences shows you how.

The Challenger Sale

Author: Matthew Dixon
Publisher: Penguin
ISBN: 1101545895
Size: 27.89 MB
Format: PDF, ePub, Docs
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What's the secret to sales success? If you're like most business leaders, you'd say it's fundamentally about relationships-and you'd be wrong. The best salespeople don't just build relationships with customers. They challenge them. The need to understand what top-performing reps are doing that their average performing colleagues are not drove Matthew Dixon, Brent Adamson, and their colleagues at Corporate Executive Board to investigate the skills, behaviors, knowledge, and attitudes that matter most for high performance. And what they discovered may be the biggest shock to conventional sales wisdom in decades. Based on an exhaustive study of thousands of sales reps across multiple industries and geographies, The Challenger Sale argues that classic relationship building is a losing approach, especially when it comes to selling complex, large-scale business-to-business solutions. The authors' study found that every sales rep in the world falls into one of five distinct profiles, and while all of these types of reps can deliver average sales performance, only one-the Challenger- delivers consistently high performance. Instead of bludgeoning customers with endless facts and features about their company and products, Challengers approach customers with unique insights about how they can save or make money. They tailor their sales message to the customer's specific needs and objectives. Rather than acquiescing to the customer's every demand or objection, they are assertive, pushing back when necessary and taking control of the sale. The things that make Challengers unique are replicable and teachable to the average sales rep. Once you understand how to identify the Challengers in your organization, you can model their approach and embed it throughout your sales force. The authors explain how almost any average-performing rep, once equipped with the right tools, can successfully reframe customers' expectations and deliver a distinctive purchase experience that drives higher levels of customer loyalty and, ultimately, greater growth.

Public Engagement And Clinical Trials New Models And Disruptive Technologies

Author: Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309219299
Size: 72.12 MB
Format: PDF, ePub, Docs
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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

Nutrition And Enhanced Sports Performance

Author: Debasis Bagchi
Publisher: Academic Press
ISBN: 0123964776
Size: 40.70 MB
Format: PDF, ePub
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Nutrition and Enhanced Sports Performance: Muscle Building, Endurance, and Strength provides a comprehensive overview to understanding the integrated impact of nutrition on performance. The book is divided into five main themes: An introductory overview of the role of nutrition in human health Various types of physical exercises, including cardiovascular training, resistance training, aerobic and anaerobic exercise, bioenergetics, and energy balance. This section also covers the nutritional requirements associated with various fitness programs, as well as exercise and nutritional requirements in special populations, including the pre-pubertal, young, elderly, and disabled. Sports and nutritional requirements. The molecular mechanisms involved in muscle building A thorough review of various food, minerals, supplements, phytochemicals, amino acids, transition metals, small molecules and other ergogenic agents that have been implicated in muscle building and human performance This book is an ideal resource for nutritionists, dietitians, exercise physiologists, health practitioners, researchers, students, athletes, trainers, and all those who wish to broaden their knowledge of nutrition and its role in human performance. Discusses the impact of nutrition, including food, minerals, vitamins, hormones, trace elements, etc., that can significantly attenuate/improve human performance and sports Addresses the molecular and cellular pathways involved in the physiology of muscle growth and the mechanisms by which nutrients affect muscle health, growth and maintenance Encompasses multiple forms of sports/performance and the salient contribution of appropriate nutrition on special populations, including nutritional guidelines and recommendations to athletes Strong focus on muscle building

The Effortless Experience

Author: Matthew Dixon
Publisher: Penguin
ISBN: 1591845815
Size: 12.41 MB
Format: PDF, Mobi
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Describes how many companies erroneously believe that customer loyalty is won by dazzling them, but that research and surveys show that loyalty is based on delivering on basic promises and offers insights for companies to use to improve brand loyalty.