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Download or read book Contract Research Organizations in the EEC. written by and published by . This book was released on 1989 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Organisation for European Economic Co-operation
Publisher :
ISBN 13 :
Total Pages : 84 pages
Book Rating : 4.3/5 ( download)
Download or read book The Organisation of Applied Research in Europe written by Organisation for European Economic Co-operation and published by . This book was released on 1954 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Danielle Jacobs
Publisher : Inst of Clinical Research
ISBN 13 : 0954934539
Total Pages : 48 pages
Book Rating : 4.9/5 (549 download)
Download or read book Patient Recruitment in Clinical Research written by Danielle Jacobs and published by Inst of Clinical Research. This book was released on 2005 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides ideas for how to improve patient recruitment for clinical trials.
Author : Franco Malerba
Publisher :
ISBN 13 :
Total Pages : 170 pages
Book Rating : 4.3/5 ( download)
Download or read book The Nascent Globalisation of Universities and Public and Quasi-public Research Organizations written by Franco Malerba and published by . This book was released on 1991 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : L. Berreur
Publisher :
ISBN 13 :
Total Pages : 540 pages
Book Rating : 4.3/5 ( download)
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:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
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.
Author : James Hogan
Publisher : Springer
ISBN 13 : 1349113441
Total Pages : 565 pages
Book Rating : 4.3/5 (491 download)
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:
Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
ISBN 13 : 1118679385
Total Pages : 1012 pages
Book Rating : 4.1/5 (186 download)
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.
Author : Thomas J. Allen
Publisher : Cambridge University Press
ISBN 13 : 0521876532
Total Pages : 415 pages
Book Rating : 4.5/5 (218 download)
Download or read book Building Technology Transfer within Research Universities written by Thomas J. Allen and published by Cambridge University Press. This book was released on 2014-09-18 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: Academic thought-leaders in the field of technology transfer analyze critically the factors behind success-oriented entrepreneurial start-up cultures on university campuses.
Author : Albert N. Link
Publisher : Springer Science & Business Media
ISBN 13 : 9400925220
Total Pages : 231 pages
Book Rating : 4.4/5 (9 download)
Download or read book Cooperative Research and Development: The Industry—University—Government Relationship written by Albert N. Link and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: We must all hang together or surely we will all hang separately. Benjamin Franklin The significant apathy that characterized relationships between indus try and universities and the adversarial nature of relationships between industry and government have both faded rapidly in the 1980s as the realities of global competition have surfaced in the United States. Both industry and government leaders articulate a number of constructs for regaining our competitiveness in world markets. One of the more fre quent strategies prescribed in this new competitiveness era is cooperation. Different individuals or groups may espouse different definitions, inter pretations, or areas of emphasis, but the overall importance of this concept is substantial. Although examples of cooperative research have existed for several decades, the number and variety of relationships have expanded rapidly in the 1980s as corporations, universities, and governments have embraced this strategy. Joint ventures involving two or three firms increased from under 200 per year in the 1970s to over 400 per year by the mid-1980s. Multiple-firm cooperative arrangements are a more recent phenomenon, made possible by the National Cooperative Research Act of 1984. By mid- 1988,81 of these industry-level consortia had formed under the provisions of the 1984 Act. The rapid growth in cooperative research and development (R&D) is primarily a response to the pressures of international competition. As a corporate strategy, cooperative R&D meets short-term needs for assets to implement new approaches for coping with intensifying competition.
Author : Jakob Miera
Publisher : Anchor Academic Publishing (aap_verlag)
ISBN 13 : 3954896982
Total Pages : 90 pages
Book Rating : 4.9/5 (548 download)
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.
Author :
Publisher :
ISBN 13 :
Total Pages : 974 pages
Book Rating : 4.:/5 (319 download)
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:
Author : Professor Sheila A M McLean
Publisher : Ashgate Publishing, Ltd.
ISBN 13 : 1409496198
Total Pages : 622 pages
Book Rating : 4.4/5 (94 download)
Download or read book First Do No Harm written by Professor Sheila A M McLean and published by Ashgate Publishing, Ltd.. This book was released on 2013-02-28 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.
Author : A A Van Dooren
Publisher : World Scientific
ISBN 13 : 9813223197
Total Pages : 535 pages
Book Rating : 4.8/5 (132 download)
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)
Author : Anthony C. Cartwright
Publisher : CRC Press
ISBN 13 : 1420081837
Total Pages : 804 pages
Book Rating : 4.4/5 (2 download)
Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author : Pieter Kubben
Publisher : Springer
ISBN 13 : 3319997130
Total Pages : 219 pages
Book Rating : 4.3/5 (199 download)
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.
Author : Sumantra Ray
Publisher : Oxford University Press
ISBN 13 : 0199608474
Total Pages : 603 pages
Book Rating : 4.1/5 (996 download)
Download or read book Oxford Handbook of Clinical and Healthcare Research written by Sumantra Ray and published by Oxford University Press. This book was released on 2016 with total page 603 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
