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Contract Research and Development Organizations-Their History, Selection, and Utilization, Gad Shayne C., Spainhour Charles B., Serota David G.


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Автор: Gad Shayne C., Spainhour Charles B., Serota David G.
Название:  Contract Research and Development Organizations-Their History, Selection, and Utilization
ISBN: 9783030430757
Издательство: Springer
Классификация:

ISBN-10: 3030430758
Обложка/Формат: Paperback
Страницы: 519
Вес: 0.63 кг.
Дата издания: 18.07.2021
Язык: English
Размер: 21.01 x 14.81 x 2.74 cm
Ссылка на Издательство: Link
Поставляется из: Германии
Описание:

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics:

- The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.

- Study directors and principal investigators.

- The nuts and bolts of study performance.

- Electronic reporting requirements - SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions).

- Consultants and their roles.

- An expanded examination of common problems and their solutions.

This book boasts complete directories to the global universe of operating labs - where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities - and for auditing studies and projects at such facilities - are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves.

In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.




Tools and Techniques for Software Development in Large Organizations: Emerging Research and Opportunities

Автор: Vishnu Pendyala
Название: Tools and Techniques for Software Development in Large Organizations: Emerging Research and Opportunities
ISBN: 1799818632 ISBN-13(EAN): 9781799818632
Издательство: Mare Nostrum (Eurospan)
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Цена: 26195.00 р.
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Описание: Discusses advanced software methods that prominent companies have adopted to develop high quality products. The book examines the various devices that organisations such as Google, Cisco, and Facebook have implemented into their production and development processes.

Tools and Techniques for Software Development in Large Organizations: Emerging Research and Opportunities

Автор: Vishnu Pendyala
Название: Tools and Techniques for Software Development in Large Organizations: Emerging Research and Opportunities
ISBN: 1799818640 ISBN-13(EAN): 9781799818649
Издательство: Mare Nostrum (Eurospan)
Цена: 22037.00 р.
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Описание: The development of software has expanded substantially in recent years. As these technologies continue to advance, well-known organizations have begun implementing these programs into the ways they conduct business. These large companies play a vital role in the economic environment, so understanding the software that they utilize is pertinent in many aspects. Researching and analyzing the tools that these corporations use will assist in the practice of software engineering and give other organizations an outline of how to successfully implement their own computational methods. Tools and Techniques for Software Development in Large Organizations: Emerging Research and Opportunities is an essential reference source that discusses advanced software methods that prominent companies have adopted to develop high quality products. This book will examine the various devices that organizations such as Google, Cisco, and Facebook have implemented into their production and development processes. Featuring research on topics such as database management, quality assurance, and machine learning, this book is ideally designed for software engineers, data scientists, developers, programmers, professors, researchers, and students seeking coverage on the advancement of software devices in today's major corporations.

Contract Research and Development Organizations-Their History, Selection, and Utilization

Автор: Gad Shayne C., Spainhour Charles B., Serota David G.
Название: Contract Research and Development Organizations-Their History, Selection, and Utilization
ISBN: 3030430723 ISBN-13(EAN): 9783030430726
Издательство: Springer
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Цена: 12577.00 р.
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Описание: Introduction.- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart.- The Pharmaceutical Development Process & Testing Requirements.- The Medical Device Development Process & Testing Requirements.- Functions and Types of CROs.- Labs in China and India.- Selection of CROs.- Study Directors and PIs.- Nuts and Bolts of Study Performance SCG/CBS.- Electronic Reporting Requirements (SEND & eCTD).- Study and Project Monitoring.- Contracting, Pricing, and Cost of Works Performed by CROs.- Consultants and their Role.- Building Relationships: Maximizing your return on Expectations with a CRO.- Common Problems and their Solutions.- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists.- K Specialized Services.- L Consultants Known to be In-Practice.- Index.

Contract Research and Development Organizations

Автор: Shayne C. Gad; Charles B. Spainhour
Название: Contract Research and Development Organizations
ISBN: 148999890X ISBN-13(EAN): 9781489998903
Издательство: Springer
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Цена: 22201.00 р.
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Описание: Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced.

Utilization Review: Information on External Review Organizations: Hrd-93-22fs

Название: Utilization Review: Information on External Review Organizations: Hrd-93-22fs
ISBN: 1289069840 ISBN-13(EAN): 9781289069841
Издательство: Неизвестно
Цена: 3449.00 р.
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Disrupting Threat Finances: Utilization of Financial Information to Disrupt Terrorist Organizations in the Twenty-First Century

Автор: Anderson Wesley J. L.
Название: Disrupting Threat Finances: Utilization of Financial Information to Disrupt Terrorist Organizations in the Twenty-First Century
ISBN: 1286865778 ISBN-13(EAN): 9781286865774
Издательство: Неизвестно
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Цена: 10658.00 р.
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Applied General Systems Research on Organizations

Автор: S. Takahashi; K. Kijima; R. Sato
Название: Applied General Systems Research on Organizations
ISBN: 4431201181 ISBN-13(EAN): 9784431201182
Издательство: Springer
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Цена: 18167.00 р.
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Описание: Illustrates organizations study with an interdisciplinary approach, emphasizing systemic properties of organizations such as interaction, hierarchy, network and emergence. This book covers dynamic aspects of organizational learning and evolution, as well as the decision making function, and information processing process.

Multilevel Theory, Research, and Methods in Organizations: Foundations, Extensions, and New Directions

Автор: Katherine J. Klein, Steve W. J. Kozlowski
Название: Multilevel Theory, Research, and Methods in Organizations: Foundations, Extensions, and New Directions
ISBN: 0787952281 ISBN-13(EAN): 9780787952280
Издательство: Wiley
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Цена: 11880.00 р.
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Описание: This SIOP (Society for International and Organizational Psychology) Frontiers Series volume updates current theory on multilevel analysis--illuminating both the larger structure of today`s organizations and their complex webs of inter-relationships--and gives methods for using multilevel theory to develop a unified organizational picture.

Integrations of Technology Utilization and Social Dynamics in Organizations

Автор: Dawn Medlin
Название: Integrations of Technology Utilization and Social Dynamics in Organizations
ISBN: 1466619481 ISBN-13(EAN): 9781466619487
Издательство: Mare Nostrum (Eurospan)
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Цена: 25502.00 р.
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Описание: Integrations of Technology Utilization and Social Dynamics in Organizations covers all aspects of social issues impacted by information technology in organizations and inter-organizational structures; this book presents the conceptualization of specific social issues and their associated constructs. It encompasses designs and infrastructures, empirical validation of social models, and case studies illustrating socialization success and failures relating to Information technology.

Tackling Wicked Problems in Complex Ecologies: The Role of Evaluation

Автор: Hopson Rodney, Cram Fiona
Название: Tackling Wicked Problems in Complex Ecologies: The Role of Evaluation
ISBN: 1503600718 ISBN-13(EAN): 9781503600713
Издательство: Mare Nostrum (Eurospan)
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Цена: 8778.00 р.
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Описание:

Tackling Wicked Problems in Complex Ecologies is a call to action, focusing on the role that evaluators can play in addressing social and economic problems. Evaluation extends beyond theories and methods, encompassing a range of proven approaches for addressing ecological complexities that drive inequities around the globe.

Bringing together leading thinkers and problem-solvers, this collection traverses the range of contexts at the frontiers of the field—from inadequate food supply and housing to unemployment and poverty. Editors Rodney Hopson and Fiona Cram demonstrate the effects of an engaged approach to evaluation, in which three considerations take center stage: its relevance, the relationships it engenders, and the responsibilities it requires. This is a handbook for tackling the social and economic problems of the twenty-first century which, though wicked, are amenable to the tools of the trade.

Current Theory and Research in Transforming Organizations

Автор: Chester A. Schriesheim, Linda L. Neider
Название: Current Theory and Research in Transforming Organizations
ISBN: 1681236133 ISBN-13(EAN): 9781681236131
Издательство: Mare Nostrum (Eurospan)
Цена: 7623.00 р.
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Описание: Perhaps the best word to describe the past fifteen or so years of the twenty first century is “change.” Spurred on by the massive layoffs, and reorganizations that took place during the recessionary period starting in late 2007, to changes in labor demographics, technology, competitiveness, and the very nature of work, business transformations have become the norm. Even the most stodgy and inflexible organizations – universities – are beginning to understand the need for radical change if they hope to be sustainable in the future. From our perspective as researchers in management, we became increasingly interested in new trends and ideas in the field of transforming business and non?profit enterprises. What are the variables associated with success? What determinants may mediate whether or not change efforts actually lead to more sustainable systems? And, how do such change efforts differ from strategic planning, which has obviously been around and used for many years? To begin answering such questions, this volume attempts to bring together a number of scholars who present conceptualizations and preliminary research insights concerning organizational change, and in two of the chapters, explore the relationship between change efforts and strategy formulation/implementation.

Handbook of Research on Character and Leadership Development in Military Schools

Автор: Mark Patrick Ryan, Timothy L. Weekes
Название: Handbook of Research on Character and Leadership Development in Military Schools
ISBN: 179986636X ISBN-13(EAN): 9781799866367
Издательство: Mare Nostrum (Eurospan)
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Цена: 37422.00 р.
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Описание: Military academies have served youth for more than a century with proud traditions of producing graduates who are scholars, leaders, and athletes who adhere to a code of honor and ethical principles as they take the knowledge, skills, and dispositions gained at those academies into higher education, the business world, military service, civic endeavors, and the broader workforce. There is a current gap and need for research that explores the various components of a K-20 military school/college education and how those components successfully produce leaders of character for our military, civic, academic, and business worlds both in the United States and abroad.

The Handbook of Research on Character and Leadership Development in Military Schools synthesizes research on the impact of military academies by providing a singular compendium of current academic studies on the graduates of military academies and the communities of which they enter after graduation. The chapters will explore the academics, leadership, character development, citizenship, athletics, and other dimensions of both global and national, and both private and public, military academies. This book is ideal for current leaders, staffs, governing board members, and alumni of military academies both in the United States and internationally along with policymakers, government officials, practitioners, researchers, academicians, and students interested in the implications of character and leadership development on individuals enrolled in or graduated from military schools.


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