Download or read book Contract Research Organizations in the EEC written by L. Berreur and published by . This book was released on 1989 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Download or read book The European Marketplace written by James Hogan and published by Springer. This book was released on 1990-11-19 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Animal Hematotoxicology written by G.O. Evans and published by CRC Press. This book was released on 2008-07-25 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hematology data from in vivo toxicology studies remains one of the most predictive measures for human risk, as the same measurements made in pre-clinical toxicology studies can be made in early clinical trials. Covering the three main blood cell types - erythrocytes, leukocytes and thrombocytes, this work is designed to clarify topics fo
Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Download or read book Directory of EEC Information Sources written by and published by . This book was released on 1991 with total page 974 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Preclinical Safety Evaluation of Biopharmaceuticals written by Joy A. Cavagnaro and published by John Wiley & Sons. This book was released on 2013-03-07 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
Download or read book Ethical Research written by Ulf Schmidt and published by . This book was released on 2020 with total page 611 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Research is a new and important book focusing on the centrality of the Declaration of Helsinki to the protection of human subjects involved in human experimentation. The text illuminates the history, nature, scope, context, and controversies that challenge modern research ethics. The editors and authors are international experts in their fields of study and each approaches the subject in a scholarly and accessible dialogue.
Download or read book CRO Contract Research Organization How Drug Research is Evolving written by Jakob Miera and published by Anchor Academic Publishing (aap_verlag). This book was released on 2014-02-01 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Macmillan Directory of Business Information Sources written by James Tudor and published by Springer. This book was released on 1989-06-18 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a three-in-one compendium of sources and resources which draws on more than a decade of experience in sourcing and analyzing market and business information. It covers over 1000 key sources and highlights the best buys.
Download or read book International Ethical Guidelines for Biomedical Research Involving Human Subjects written by Council for International Organizations of Medical Sciences and published by World Health Organization. This book was released on 2002 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Download or read book First Do No Harm written by Sheila A. M. McLean and published by Routledge. This book was released on 2016-04-15 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection brings together essays from leading figures in the field of medical law and ethics which address the key issues currently challenging scholars in the field. It has also been compiled as a lasting testimony to the work of one of the most eminent scholars in the area, Professor Ken Mason. The collection marks the academic crowning of a career which has laid one of the foundation stones of an entire discipline. The wide-ranging contents and the standing of the contributors mean that the volume will be an invaluable resource for anyone studying or working in medical law or medical ethics.
Download or read book More than an Ally written by Maryanne Kelton and published by Routledge. This book was released on 2016-12-05 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the ascendancy of the Coalition government in 1996 there was a marked shift of emphasis directed to deepening Australia's relations with America. The Coalition government strategically linked security and economic well-being and this linking was contextualized by threats both internal and external. By deepening the relationship of the US alliance in foreign, trade and defence policies, the Australian government sought to resonate on inherited and conservative perceptions of threat in the domestic environment. Maryanne Kelton introduces specific cases to demonstrate both the intensity and complexity of dealing with the US. Through these empirical studies the government's approach is examined across trade, security and industry sectors. The book adds to the current debate as it provides an explanatory framework for understanding the Australian government's choices in its relations with the USA across the broader spectrum of security issues.
Download or read book Clinical Research Monitoring A European Approach written by A A Van Dooren and published by World Scientific. This book was released on 2017-09-21 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged.This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research.Related Link(s)
