Outsourcing Clinical Development

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Outsourcing Clinical Development

Author : Jane Baguley
Publisher : CRC Press
ISBN 13 : 1317084586
Total Pages : 192 pages
Book Rating : 4.3/5 (17 download)

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Book Synopsis Outsourcing Clinical Development by : Jane Baguley

Download or read book Outsourcing Clinical Development written by Jane Baguley and published by CRC Press. This book was released on 2016-05-13 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.

Outsourcing Clinical Research Projects

Author : David Bryde
Publisher : Inst of Clinical Research
ISBN 13 : 1905238053
Total Pages : 40 pages
Book Rating : 4.9/5 (52 download)

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Book Synopsis Outsourcing Clinical Research Projects by : David Bryde

Download or read book Outsourcing Clinical Research Projects written by David Bryde and published by Inst of Clinical Research. This book was released on 2007 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the decision-making process of out-sourcing and provides a model of the process. It covers topics associated with finding an appropriate Clinical Research Organisation, including: the feasibility process, types of contracts, legal documentation and the working relationship between client and sub-contractor.

Clinical Trials in Latin America: Where Ethics and Business Clash

Author : Nuria Homedes
Publisher : Springer Science & Business Media
ISBN 13 : 3319013637
Total Pages : 291 pages
Book Rating : 4.3/5 (19 download)

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Book Synopsis Clinical Trials in Latin America: Where Ethics and Business Clash by : Nuria Homedes

Download or read book Clinical Trials in Latin America: Where Ethics and Business Clash written by Nuria Homedes and published by Springer Science & Business Media. This book was released on 2013-11-29 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.

Clinical Development

Author : Janice Steiner
Publisher : CRC Press
ISBN 13 : 1000725022
Total Pages : 246 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Clinical Development by : Janice Steiner

Download or read book Clinical Development written by Janice Steiner and published by CRC Press. This book was released on 2019-11-14 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource. The book provides expert advice on ways to reduce delays and lost market opportunities, minimize development time, better understand the process and regulatory requirements, and plan and analyze clinical development and testing programs. The author combines text, graphs, and charts to show how a company moves a product through the complex process from discovery to market. The result is a complete analysis of the drug development process in easy-to-understand language and easy-to-implement action steps.

Outsourcing in Clinical Drug Development

Author : Roy Drucker
Publisher : CRC Press
ISBN 13 : 9781574911121
Total Pages : 268 pages
Book Rating : 4.9/5 (111 download)

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Book Synopsis Outsourcing in Clinical Drug Development by : Roy Drucker

Download or read book Outsourcing in Clinical Drug Development written by Roy Drucker and published by CRC Press. This book was released on 2002-08-15 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

China Rx

Author : Rosemary Gibson
Publisher : Prometheus Books
ISBN 13 : 1633883817
Total Pages : 306 pages
Book Rating : 4.6/5 (338 download)

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Book Synopsis China Rx by : Rosemary Gibson

Download or read book China Rx written by Rosemary Gibson and published by Prometheus Books. This book was released on 2018 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of Americans are taking prescription drugs made in China and don't know it-- and pharmaceutical companies are not eager to tell them. This probing book examines the implications for the quality and availability of vital medicines for consumers. Several decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But with the rise of globalization, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. China's biggest impact on the US drug supply is making essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. The authors convincingly argue that there are at least two major problems with this scenario. First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary. Second, lapses in safety standards and quality control in Chinese manufacturing are a risk. Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications that prompted reform. This is a disturbing, well-researched book and a wake-up call for improving the current system of drug supply and manufacturing.

Pharmaceutical Outsourcing: Discovery and Preclinical Services

Author : William C. Stevens Jr.
Publisher : Lulu.com
ISBN 13 : 0984904905
Total Pages : 277 pages
Book Rating : 4.9/5 (849 download)

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Book Synopsis Pharmaceutical Outsourcing: Discovery and Preclinical Services by : William C. Stevens Jr.

Download or read book Pharmaceutical Outsourcing: Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!

When Experiments Travel

Author : Adriana Petryna
Publisher : Princeton University Press
ISBN 13 : 1400830826
Total Pages : 271 pages
Book Rating : 4.4/5 (8 download)

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Book Synopsis When Experiments Travel by : Adriana Petryna

Download or read book When Experiments Travel written by Adriana Petryna and published by Princeton University Press. This book was released on 2009-04-27 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.

Oral Formulation Roadmap from Early Drug Discovery to Development

Author : Elizabeth Kwong
Publisher : John Wiley & Sons
ISBN 13 : 1118907876
Total Pages : 272 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Oral Formulation Roadmap from Early Drug Discovery to Development by : Elizabeth Kwong

Download or read book Oral Formulation Roadmap from Early Drug Discovery to Development written by Elizabeth Kwong and published by John Wiley & Sons. This book was released on 2017-01-03 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

Dictionary of Global Bioethics

Author : Henk ten Have
Publisher : Springer Nature
ISBN 13 : 3030541614
Total Pages : 1063 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis Dictionary of Global Bioethics by : Henk ten Have

Download or read book Dictionary of Global Bioethics written by Henk ten Have and published by Springer Nature. This book was released on 2021-05-26 with total page 1063 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Dictionary presents a broad range of topics relevant in present-day global bioethics. With more than 500 entries, this dictionary covers organizations working in the field of global bioethics, international documents concerning bioethics, personalities that have played a role in the development of global bioethics, as well as specific topics in the field.The book is not only useful for students and professionals in global health activities, but can also serve as a basic tool that explains relevant ethical notions and terms. The dictionary furthers the ideals of cosmopolitanism: solidarity, equality, respect for difference and concern with what human beings- and specifically patients - have in common, regardless of their backgrounds, hometowns, religions, gender, etc. Global problems such as pandemic diseases, disasters, lack of care and medication, homelessness and displacement call for global responses.This book demonstrates that a moral vision of global health is necessary and it helps to quickly understand the basic ideas of global bioethics.

Outsourcing Clinical Development

Author : Jane Baguley
Publisher : CRC Press
ISBN 13 : 1317084578
Total Pages : 207 pages
Book Rating : 4.3/5 (17 download)

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Book Synopsis Outsourcing Clinical Development by : Jane Baguley

Download or read book Outsourcing Clinical Development written by Jane Baguley and published by CRC Press. This book was released on 2016-05-13 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.

The Agile Approach to Adaptive Research

Author : Michael J. Rosenberg
Publisher : John Wiley & Sons
ISBN 13 : 0470599677
Total Pages : 296 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis The Agile Approach to Adaptive Research by : Michael J. Rosenberg

Download or read book The Agile Approach to Adaptive Research written by Michael J. Rosenberg and published by John Wiley & Sons. This book was released on 2010-02-18 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, and demonstrates why it is an essential evolutionary step toward improving drug research and development. Chapters explore such subjects as: The adaptive concept Design and operational adaptations Sample-size reestimation Agile clinical development Safety and dose finding Statistics in adaptive research, including frequentist and Bayesian approaches Data management technologies The future of clinical development By combining centuries-old intellectual foundations, recent technological advances, and modern management techniques, adaptive research preserves the integrity and validity of clinical research but dramatically improves efficiency.

Outsourcing Economics

Author : William Milberg
Publisher : Cambridge University Press
ISBN 13 : 1107355222
Total Pages : 377 pages
Book Rating : 4.1/5 (73 download)

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Book Synopsis Outsourcing Economics by : William Milberg

Download or read book Outsourcing Economics written by William Milberg and published by Cambridge University Press. This book was released on 2013-04-29 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: Outsourcing Economics has a double meaning. First, it is a book about the economics of outsourcing. Second, it examines the way that economists have understood globalization as a pure market phenomenon, and as a result have 'outsourced' the explanation of world economic forces to other disciplines. Markets are embedded in a set of institutions - labor, government, corporate, civil society, and household - that mold the power asymmetries that influence the distribution of the gains from globalization. In this book, William Milberg and Deborah Winkler propose an institutional theory of trade and development starting with the growth of global value chains - international networks of production that have restructured the global economy and its governance over the past twenty-five years. They find that offshoring leads to greater economic insecurity in industrialized countries that lack institutions supporting workers. They also find that offshoring allows firms to reduce domestic investment and focus on finance and short-run stock movements.

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309172802
Total Pages : 88 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine

Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Contract Research and Development Organizations

Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 146140049X
Total Pages : 213 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Contract Research and Development Organizations by : Shayne C. Gad

Download or read book Contract Research and Development Organizations written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2011-08-04 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. 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. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

Outsourcing America

Author : Ron Hira
Publisher : AMACOM Div American Mgmt Assn
ISBN 13 : 0814416284
Total Pages : 290 pages
Book Rating : 4.8/5 (144 download)

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Book Synopsis Outsourcing America by : Ron Hira

Download or read book Outsourcing America written by Ron Hira and published by AMACOM Div American Mgmt Assn. This book was released on 2008-04-30 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the most controversial topics in the news is the outsourcing of American jobs to other countries. Outsourced jobs have extended well beyond the manufacturing sector to include white-collar professionals, particularly in information technology, financial services, and customer service. Outsourcing America reveals just how much outsourcing is taking place, what its impact has been and will continue to be, and what can be done about the loss of jobs. More than an exposé, Outsourcing America shows how offshoring is part of the historical economic shift toward globalism and free trade, and demonstrates its impact on individual lives and communities. In addition, the book now features a new chapter on immigration policies and outsourcing, and advice on how individuals can avoid becoming victims of outsourcing. The authors discuss policies that countries like India and China use to attract U.S. industries, and they offer frank recommendations that business and political leaders must consider in order to confront this crisis—and bring more high-paying jobs back to the U.S.A.

Outsourcing Welfare

Author : Roy Germano
Publisher : Oxford University Press
ISBN 13 : 019086284X
Total Pages : 241 pages
Book Rating : 4.1/5 (98 download)

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Book Synopsis Outsourcing Welfare by : Roy Germano

Download or read book Outsourcing Welfare written by Roy Germano and published by Oxford University Press. This book was released on 2018 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Remittances and the politics of austerity -- Outsourcing social welfare: how migrants replaced the state during Mexico's market transition -- How remittances prevent social unrest: evidence from the Mexican countryside -- Optimism in times of crisis: remittances and economic security in Africa, the Caribbean, Latin America, and the Middle East -- They came banging pots and pans: remittances and government approval in Sub-Saharan Africa during the food crisis -- No left turn: remittances and incumbent support in Mexico's closely-contested 2006 presidential election -- Conclusion