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| contract research organization business model: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| contract research organization business model: Contract Research and Development Organizations Shayne C. Gad, Charles B. Spainhour, 2011-08-04 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. |
| contract research organization business model: The Role of Purchasers and Payers in the Clinical Research Enterprise Institute of Medicine, Board on Health Sciences Policy, Clinical Research Roundtable, 2002-06-14 In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective. |
| contract research organization business model: 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. |
| contract research organization business model: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| contract research organization business model: Contract Research and Manufacturing Services (CRAMS) in India Milind Antani, Gowree Gokhale, 2012-10-31 The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. - Simple and accessible presentation using tables, charts and diagrams - Practical tips from leading practitioners - Inclusion of relevant case laws and other legal considerations |
| contract research organization business model: 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. |
| contract research organization business model: Improving and Accelerating Therapeutic Development for Nervous System Disorders Institute of Medicine, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2014-02-06 Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials. |
| contract research organization business model: 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 |
| contract research organization business model: Social Aspects of Drug Discovery, Development and Commercialization Odilia Osakwe, Syed A.A. Rizvi, 2016-02-18 Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society. - Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects - Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development - Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China - Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society |
| contract research organization business model: Clinical Pharmacy Education, Practice and Research Dixon Thomas, 2018-11-23 Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. - Covers the core information needed for pharmacy practice courses - Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge - Designed for educational settings, but also useful as a refresher for advanced students and researchers |
| contract research organization business model: The Innovator's Prescription: A Disruptive Solution for Health Care Clayton M. Christensen, Jerome H. Grossman, Jason Hwang, 2008-10-31 A groundbreaking prescription for health care reform--from a legendaryleader in innovation . . . Our health care system is in critical condition. Each year, fewer Americans can afford it, fewer businesses can provide it, and fewer government programs can promise it for future generations. We need a cure, and we need it now. Harvard Business School’s Clayton M. Christensen—whose bestselling The Innovator’s Dilemma revolutionized the business world—presents The Innovator’s Prescription, a comprehensive analysis of the strategies that will improvehealth care and make it affordable. Christensen applies the principles of disruptive innovation to the broken health care system with two pioneers in the field—Dr. Jerome Grossman and Dr. Jason Hwang. Together, they examine arange of symptoms and offer proven solutions. YOU’LL DISCOVER HOW “Precision medicine” reduces costs and makes good on the promise of personalized care Disruptive business models improve quality, accessibility, and affordability by changing the way hospitals and doctors work Patient networks enable better treatment of chronic diseases Employers can change the roles they play in health care to compete effectively in the era of globalization Insurance and regulatory reforms stimulate disruption in health care |
| contract research organization business model: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| contract research organization business model: Business Model Innovation Nicolai J. Foss, Tina Saebi, 2015 Business model innovation is an important source of competitive advantage and corporate renewal. An increasing number of companies have to innovate their business models, not just because of competitive forces but also because of the ongoing change from product-based to service-based business models. Yet, business model innovation also involves organizational change process that challenges existing processes, structures and modes of control. This volume features thirteen chapters written by authorities on business model innovation. The specific angle, and the novel feature of this book, is to thoroughly examine the organizational dimension of business model innovation. Drawing on organizational theory and empirical observation, the contributors specifically highlight organizational design aspects of business model innovation, focusing on how reward systems, power distributions, routines and standard operating procedures, the allocation of authority, and other aspects of organizational structure and control should be designed to support the business model the firm chooses. Also discussed is how existing organizational structures, capabilities, beliefs, cultures and so on influence the firm's ability to flexibly change to new business models. |
| contract research organization business model: CRO – Contract Research Organization: How Drug Research is Evolving Jakob Miera, 2014-02-01 This book deals in general with mergers & acquisitions in the CRO industry, and more specifically with reasons for M&A, success factors during the M&A process, and why M&A can fail in the Contract Research Organization industry. The pharmaceutical industry faces increasing obstacles in respect to the development and introduction of new medications. That has to do with stricter requirements for admission and sharper controls by authorities. Today, the research and development of a new drug can easily consume more than $800 million and lasting between 10 and 15 years. Due to these facts pharmaceutical companies are looking for an alternative in the drug development process. A popular alternative is the outsourcing or in-house working with Contract Research Organizations (CRO). CRO are specialized in coordination and monitoring of drug development activities. The size of the CRO market in 2012 was around $32 billion and had an estimated market growth of around 9 – 12% for 2013. Increased outsourcing and allocation of R&D money towards CRO reflects a driving force for prospective growth. Contract Research Organizations consider mergers & acquisitions as a vital solution to achieve their objectives. |
| contract research organization business model: When Experiments Travel Adriana Petryna, 2009-04-27 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. |
| contract research organization business model: Critical Thinking in Clinical Research Felipe Fregni, Ben M. W. Illigens, 2018 Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties. |
| contract research organization business model: The Truth About the Drug Companies Marcia Angell, 2005-08-09 During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change. Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers. Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective. The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control. |
| contract research organization business model: Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine, Board on Health Sciences Policy, Committee on Conflict of Interest in Medical Research, Education, and Practice, 2009-09-16 Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine. |
| contract research organization business model: Medical Research for Hire Jill A. Fisher, 2009 Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians. According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer free doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care. A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden |
| contract research organization business model: Encyclopedia of Pharmacy Practice and Clinical Pharmacy , 2019-06-28 Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos |
| contract research organization business model: Psychological Contracts in Organizations Denise Rousseau, 1995-05-18 Bringing together a wide range of theory from social and cognitive psychology, organizational behaviour, organizational learning and the management of change, this text draws useful conclusions about important psychological processes. |
| contract research organization business model: New Drug Development J. Rick Turner, 2010-07-16 New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials. |
| contract research organization business model: Publishing and Presenting Clinical Research Warren S. Browner, 2012-03-19 Publishing and Presenting Clinical Research, Fourth Edition is an excellent primer for investigators who wish to learn how to organize, present, and publish results of their research. Written by an experienced clinical researcher and editor, it uses hundreds of examples, tables and figures to show how to produce successful abstracts, posters, oral presentations, and manuscripts for publication. This book also serves as a companion to the popular text, Designing Clinical Research. This edition contains the latest: • Guidance on getting work accepted in medical journals and at scientific meetings • Examples of the do’s and don’ts of data presentation • Explanations of confusing statistical terminology • Templates to get started and avoid writers’ block • Tips for creating simple graphics and tables • Help for those who are not fluent in English • Suggestions about getting the most from a poster session • Checklists for each section of a manuscript or presentation • Advice about authorship and responding to reviewers’ comments Plus with this edition, there is access to a companion website with fully searchable text so you can access the content anytime, anywhere. |
| contract research organization business model: Modern CNS Drug Discovery Rudy Schreiber, 2021-06-17 This textbook provides a comprehensive overview of the currently used concepts, approaches and technologies in the discovery and development of new treatments for the full spectrum of disorders of the central nervous system. It guides the reader through all essential steps, from finding an innovative idea, to the registration of a new drug. Divided into four sections, the book starts by presenting a broad perspective on current approaches in central nervous system (CNS) drug discovery. The second section addresses the generation of ideas for the identification of targets and novel treatment strategies; covers core functions in early discovery, and provides an example of a novel treatment paradigm: brain stimulation. The third section highlights strategies and technologies in translational CNS drug discovery. In an effort to bridge the gap between discovery and clinical development, it also covers brain imaging, EEG and cognitive testing approaches. The fourth section extensively discusses the clinical phase of drug development, covering the basics of early clinical testing for psychopharmacological drugs. The book’s final chapter addresses the registration for newly developed drugs. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments in drug discovery. Offering in-depth insights into the world of drug development, it represents essential reading for early researchers who want to prepare for a career in drug discovery in academia or industry. |
| contract research organization business model: The Role of NIH in Drug Development Innovation and Its Impact on Patient Access National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Health Care Services, 2020-01-27 To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop. |
| contract research organization business model: Business Modeling for Life Science and Biotech Companies Alberto Onetti, Antonella Zucchella, 2014-03-21 Most books on the biotechnology industry focus on scientific and technological challenges, ignoring the entrepreneurial and managerial complexities faced bio-entrepreneurs. The Business Models for Life Science Firms aims to fill this gap by offering managers in this rapid growth industry the tools needed to design and implement an effective business model customized for the unique needs of research intensive organizations. Onetti and Zucchella begin by unpacking the often-used ‘business model’ term, examining key elements of business model conceptualization and offering a three tier approach with a clear separation between the business model and strategy: focus, exploring the different activities carried out by the organization; locus, evaluating where organizational activities are centered; and modus, testing the execution of the organization’s activities. The business model thus defines the unique way in which a company delivers on its promise to its customers. The theory and applications adopt a global approach, offering business cases from a variety of biotech companies around the world. |
| contract research organization business model: Model Rules of Professional Conduct American Bar Association. House of Delegates, Center for Professional Responsibility (American Bar Association), 2007 The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts. |
| contract research organization business model: Drawdown Paul Hawken, 2017-04-18 • New York Times bestseller • The 100 most substantive solutions to reverse global warming, based on meticulous research by leading scientists and policymakers around the world “At this point in time, the Drawdown book is exactly what is needed; a credible, conservative solution-by-solution narrative that we can do it. Reading it is an effective inoculation against the widespread perception of doom that humanity cannot and will not solve the climate crisis. Reported by-effects include increased determination and a sense of grounded hope.” —Per Espen Stoknes, Author, What We Think About When We Try Not To Think About Global Warming “There’s been no real way for ordinary people to get an understanding of what they can do and what impact it can have. There remains no single, comprehensive, reliable compendium of carbon-reduction solutions across sectors. At least until now. . . . The public is hungry for this kind of practical wisdom.” —David Roberts, Vox “This is the ideal environmental sciences textbook—only it is too interesting and inspiring to be called a textbook.” —Peter Kareiva, Director of the Institute of the Environment and Sustainability, UCLA In the face of widespread fear and apathy, an international coalition of researchers, professionals, and scientists have come together to offer a set of realistic and bold solutions to climate change. One hundred techniques and practices are described here—some are well known; some you may have never heard of. They range from clean energy to educating girls in lower-income countries to land use practices that pull carbon out of the air. The solutions exist, are economically viable, and communities throughout the world are currently enacting them with skill and determination. If deployed collectively on a global scale over the next thirty years, they represent a credible path forward, not just to slow the earth’s warming but to reach drawdown, that point in time when greenhouse gases in the atmosphere peak and begin to decline. These measures promise cascading benefits to human health, security, prosperity, and well-being—giving us every reason to see this planetary crisis as an opportunity to create a just and livable world. |
| contract research organization business model: Evolution of the Post-Bureaucratic Organization Malizia, Pierfranco, Cannavale, Chiara, Maimone, Fabrizio, 2017-01-05 Continuous improvements in business operations have allowed companies more opportunities to grow and expand. This not only leads to higher success in increasing day-to-day profits, but it enhances overall organizational productivity. Evolution of the Post-Bureaucratic Organization is a pivotal source of research containing integrated and consistent theoretical frameworks on post-bureaucratic organizations, multidisciplinary perspectives, and provides case studies related to the critical aspects of the emergence of post-bureaucratic organizations. Featuring extensive coverage across a range of relevant perspectives and topics, such as business ethics, organizational communication, and cultural perspectives, this book is ideally designed for scholars, PhD and post-graduate university students, managers, and practitioners. |
| contract research organization business model: Business Models for Sustainability Peter E. Wells, 2013-10-01 Business Models for Sustainability breaks new ground by combining three important insights. First, achieving sustainability requires socio-technical transitions that entail new technologies, production processes, lifestyles, and consumption patterns. Second, firms play crucial roles in mediating between sustainable production and consumption. Third, radical innovations require organizational innovations and new business models. Peter Wells successfully combines these big picture ideas with rich in-depth case studies drawing on years of accumulated expertise. Highly recommended. Frank W. Geels, University of Manchester, UK and Chairman of the Sustainability Transitions Research Network With increasing awareness that innovative technology alone is insufficient to make sustainable lifestyles a reality, this book brings into sharp focus the need to create radical new business models. This insightful book provides a theoretically grounded but also realistic account of how the design of business models can be a critical component in the overall transition to sustainability, and one that transcends the usual focus on innovative technology. Weaving together key principles and components for business sustainability, the book highlights five very different pathways to the future for sectors ranging from microbreweries and printing through to clothing, mobility and plastics. Business has only just started the first few tentative steps towards a very different approach to creating and sustaining value, but this book concludes that enormous opportunities will emerge alongside new ways of creating and capturing value. Academics and postgraduate students in the fields of sustainable business, business organisations and industrial ecology will find this book brings a greater understanding of business strategy and structure to the discipline. While traditionally referenced and structured, this academic book is accessibly written with key principles that may also appeal to the consultant community. |
| contract research organization business model: The Offshoring of Engineering National Academy of Engineering, Committee on the Offshoring of Engineering, 2008-08-14 The engineering enterprise is a pillar of U.S. national and homeland security, economic vitality, and innovation. But many engineering tasks can now be performed anywhere in the world. The emergence of offshoring- the transfer of work from the United States to affiliated and unaffiliated entities abroad - has raised concerns about the impacts of globalization. The Offshoring of Engineering helps to answer many questions about the scope, composition, and motivation for offshoring and considers the implications for the future of U.S. engineering practice, labor markets, education, and research. This book examines trends and impacts from a broad perspective and in six specific industries - software, semiconductors, personal computer manufacturing, construction engineering and services, automobiles, and pharmaceuticals. The Offshoring of Engineering will be of great interest to engineers, engineering professors and deans, and policy makers, as well as people outside the engineering community who are concerned with sustaining and strengthening U.S. engineering capabilities in support of homeland security, economic vitality, and innovation. |
| contract research organization business model: Strategic Business Planning Clive Reading, 2002 Offers a unique business planning system that will improve the performance and competitive position of any commercial or not-for-profit organization. |
| contract research organization business model: Research and Development in the Pharmaceutical Industry (A CBO Study) Congressional Budget Office, 2013-06-09 Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation... |
| contract research organization business model: Nonclinical Study Contracting and Monitoring William F. Salminen, Joe M. Fowler, James Greenhaw, 2012-12-31 Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. - Includes both the big picture look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step - Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues - Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process - Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book |
| contract research organization business model: Strategic Sourcing in the New Economy Bonnie Keith, Kate Vitasek, Karl Manrodt, Jeanne Kling, 2016-01-12 This book provides a comprehensive overview of each of the sourcing business model. Readers will master the art and science of strategic sourcing by being able to chart a unique path that fits their capacity to apply more the full continuum of strategic sourcing concepts and tools. |
| contract research organization business model: Clinical Research in Asia U Sahoo, 2012-05-25 Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research |
| contract research organization business model: Biotechnology Entrepreneurship Craig Shimasaki, 2014-04-08 As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts |
| contract research organization business model: A Practical Guide to Drug Development in Academia Daria Mochly-Rosen, Kevin Grimes, 2014-07-08 A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet. Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form. |
| contract research organization business model: Clinical Trials Handbook Shayne Cox Gad, 2009-06-17 Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development. |
英語「contract」の意味・使い方・読み方 | Weblio英和辞書
「contract」の意味・翻訳・日本語 - 契約、約定、請負、契約書、婚約、(contract bridge で、スーツ と獲得予定のトリッ …
英語「appendix」の意味・使い方・読み方 | Weblio英和辞書
3. The report has an appendix with the survey results.（その報告書には調査結果の付録がある。）4. The company …
英語「contact」の意味・使い方・読み方 | Weblio英和辞書
「contact」の意味・翻訳・日本語 - 接触、触れ合い、交際、有力な知人、縁故、手づる、コネ、(商売上の)橋渡し役、接点(装 …
英語「provide」の意味・使い方・読み方 | Weblio英和辞書
The contract provides that the work will be completed by the end of the year.（契約書には年末までに作業が完 …
英語「define」の意味・使い方・読み方 | Weblio英和辞書
The contract defines the duties of each party.（契約書には各当事者の義務が明確にされている。 4. The law defines …
英語「contract」の意味・使い方・読み方 | Weblio英和辞書
「contract」の意味・翻訳・日本語 - 契約、約定、請負、契約書、婚約、(contract bridge で、スーツ と獲得予定のトリック 数の)契約取り決め、殺し屋を雇う契約｜Weblio英和・和英辞書
英語「appendix」の意味・使い方・読み方 | Weblio英和辞書
3. The report has an appendix with the survey results.（その報告書には調査結果の付録がある。）4. The company made an appendix to the contract.（会社は契約書に付録をつけた。） 5. An …
英語「contact」の意味・使い方・読み方 | Weblio英和辞書
「contact」の意味・翻訳・日本語 - 接触、触れ合い、交際、有力な知人、縁故、手づる、コネ、(商売上の)橋渡し役、接点(装置)、相接｜Weblio英和・和英辞書
英語「provide」の意味・使い方・読み方 | Weblio英和辞書
The contract provides that the work will be completed by the end of the year.（契約書には年末までに作業が完了することが規定されている。 4. The hotel provides all guests with complimentary …
英語「define」の意味・使い方・読み方 | Weblio英和辞書
The contract defines the duties of each party.（契約書には各当事者の義務が明確にされている。 4. The law defines theft as the act of taking someone else's property without permission.（法律では …
英和辞典・和英辞典 - Weblio辞書
約489万語収録の英和辞典・和英辞典。英語のイディオムや熟語も対応している他、英語の発音を音声でも提供。無料で使える日本最大級のオンライン英語辞書サービス。
英語「amendment」の意味・使い方・読み方 | Weblio英和辞書
make an amendment to a contract発音を聞く 例文帳に追加. 契約を改正する. - 研究社 新英和中辞典
英語「issue」の意味・使い方・読み方 | Weblio英和辞書
「issue」とは、「問題」「議題」「発行物」「号」「子孫」などの意味を持つ英単語であり、また「発行する」「発する」「出す」といった動作を表す動詞としても使用される。
英語「Contraction」の意味・使い方・読み方 | Weblio英和辞書
「Contraction」の意味・翻訳・日本語 - 短縮(すること)、収縮、(額・まゆを)ひそめること、(筋肉、特に出産時の子宮の)収縮、短縮、縮約、短縮形、作ること、かかること｜Weblio英和・和英辞書
英語「annex」の意味・使い方・読み方 | Weblio英和辞書
「annex」の意味・翻訳・日本語 - 付加する、添付する、(…に)付加する、併合する、(…に)併合する、盗む、着服する｜Weblio英和・和英辞書
