Download or read book The Selection and Use of Contract Research Organizations written by Shayne C. Gad and published by CRC Press. This book was released on 2003-07-03 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your

Download or read book The Selection and Use of Contract Research Organizations written by Shayne C. Gad and published by CRC Press. This book was released on 2004-06-02 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your essential guide to choosing the best provider. A history of the CRO industry, audit checklists, and overviews of both the pharmaceutical and medical device development processes create a comprehensive overview of how to successfully select and manage a CRO for your project. The book also discusses: Guidance for selection, protocol and contract development, project management and monitoring of work Common pitfalls and problems - how to avoid them, and how to solve them if they do occur How to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and timely production Prototype forms and templates for increasing coordination between multiple working groups A series of appendices covering hundreds of prominent service providers worldwide, including contact information Operative regulations and laws In addition to providing fundamental guidance on how to select and manage a CRO in the product development process, this reference also includes a set of eight databases that contain contact information for prominent service providers in North America, Europe, and Japan, and overviews of services they offer. It is a complete resource for professionals in biotechnology, and pharmaceutical and medical device development.

Download or read book The Selection and Use of Contract Research Organizations written by Shayne C. Gad and published by CRC Press. This book was released on 2003-07-03 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your

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.

Download or read book Contract Research and Development Organizations Their History Selection and Utilization written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-07-17 with total page 515 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Download or read book Principles of Clinical Research written by Ignazio Di Giovanna and published by Routledge. This book was released on 2001 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials.

Download or read book Understanding Clinical Research written by Renato D. Lopes and published by McGraw Hill Professional. This book was released on 2013-05-22 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

Download or read book Career Opportunities in Clinical Drug Research written by Rebecca Jane Anderson and published by Rebecca Anderson. This book was released on 2010 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: "It is simply amazing to me that so many of my industry coworkers stumbled upon their careers in clinical research, like I did, merely by chance. In most cases, once those opportunities were presented to us, we found fulfilling and successful careers. Undoubtedly, other eager job seekers would also find this career path attractive. If only someone would tell them about it."

Download or read book Critical Thinking in Clinical Research written by Felipe Fregni and published by Oxford University Press. This book was released on 2018 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Download or read book Global Clinical Trials Playbook written by Menghis Bairu and published by Academic Press. This book was released on 2012-06-12 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Download or read book New Drug Approval Process written by Richard A. Guarino and published by CRC Press. This book was released on 2016-04-19 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt: The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step

Download or read book Psychological Contracts in Organizations written by Denise Rousseau and published by SAGE. This book was released on 1995-05-18 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.