Computer Systems Validation In Clinical Research
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Computer Systems Validation In Clinical Research
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Author : ACDM/PSI Working Party on Computer Systems Validation
language : en
Publisher:
Release Date : 1997
Computer Systems Validation In Clinical Research written by ACDM/PSI Working Party on Computer Systems Validation and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with categories.
Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2003-12-18
Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-12-18 with Medical categories.
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality
Pharmaceutical Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Clinical Trials Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2009-06-17
Clinical Trials Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-06-17 with Science categories.
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.
G3p Good Privacy Protection Practice In Clinical Research
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Author : Karl-Heinz Schriever
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2014-10-02
G3p Good Privacy Protection Practice In Clinical Research written by Karl-Heinz Schriever and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-02 with Medical categories.
Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection. The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented. Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.
Validating Corporate Computer Systems
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2000-05-31
Validating Corporate Computer Systems written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-05-31 with Medical categories.
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
Good Clinical Laboratory And Manufacturing Practices
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Author : Phillip A. Carson
language : en
Publisher: Royal Society of Chemistry
Release Date : 2007
Good Clinical Laboratory And Manufacturing Practices written by Phillip A. Carson and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Science categories.
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation
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Author : Orlando Lopez
language : en
Publisher: Taylor & Francis
Release Date : 2018-10-02
Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-02 with Business & Economics categories.
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Clinical Research Monitoring A European Approach
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Author : A A Van Dooren
language : en
Publisher: World Scientific
Release Date : 2017-09-21
Clinical Research Monitoring A European Approach written by A A Van Dooren and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-21 with Medical categories.
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)
Epidemiologic Research On Real World Medical Data In Japan
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Author : Naoki Nakashima
language : en
Publisher: Springer Nature
Release Date : 2022-06-03
Epidemiologic Research On Real World Medical Data In Japan written by Naoki Nakashima and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-06-03 with Medical categories.
This book analyzes the development of medical big data projects in Japan.Japan is experiencing unprecedented population aging, and labor productivity has decreased accordingly. Big data analysis of the Japanese medical real-world database (RWD) has the potential to tackle this issue.To allow readers to gain an understanding of Japanese medical big data analysis, the book discusses the original Japanese system that generates medical RWDs in the hospital medical records system, the nationwide standardized health checkup system, and the public medical insurance system in Japan.After introducing four major big data projects in the healthcare–medical field in Japan, the book explains the importance of creating information standards to maintain data quality and to analyze medical big data. It enables readers to analyze which standards are installed in which RWDs, how the standards are maintained, and which issues are prevalent in Japan.This book also describes the ethical processes involved in big data projects involving medical RWDs in Japan.