Collaborative Genomics Projects: A Comprehensive Guide contains operational procedures, policy considerations, and the many lessons learned by The Cancer Genome Atlas Project. This book guides the reader through methods in patient sample acquisition, the establishment of data generation and analysis pipelines, data storage and dissemination, quality control, auditing, and reporting. This book is essential for those looking to set up or collaborate within a large-scale genomics research pro...

In this fully revised and expanded fourth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The books five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glos...

Ready to take your IT skills to the healthcare industry? This concise book provides a candid assessment of the US healthcare system as it ramps up its use of electronic health records (EHRs) and other forms of IT to comply with the government’s Meaningful Use requirements. It’s a tremendous opportunity for tens of thousands of IT professionals, but it’s also a huge challenge: the program requires a complete makeover of archaic records systems, workflows, and other practices now in place.

A must-have guide for any professional in the drug manufacturing industryThe Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.This book provides a...

The aims and scope of the second edition are unchanged from the first edition. The major market is in health informatics education. The three part format, which covers principles of health interoperability, HL7 and interchange formats, and SNOMED CT and clinical terminology, works well. In the US, The ONC (Office of the National Coordinator for Health Information Technology) has estimated that the HITECH stimulus will create more than 50,000 new jobs for health informatics professionals, w...

Computational biology drives discovery through its use of high-throughput informatics approaches. This book provides a road map of the current drug development process and how computational biology approaches play a critical role across the entire drug discovery pipeline. Through the use of previously unpublished, real-life case studies the impact of a range of computational approaches are discussed at various phases of the pipeline. Additionally, a focus section provides innovative visual...

Over the years, medical informatics has matured into a true scientific discipline. Fundamental and applied aspects are now taught in various fields of health, including medicine, dentistry, pharmacy, nursing and public health. Medical informatics is also often included in the curricula of many other disciplines, including the life sciences, engineering and economics.Medical informatics is a complex and rapidly changing discipline. Relatively few books have been published on the sub...

This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also prov...

Despite its high cost, the US healthcare system produces relatively short life spans, and is wasteful, inefficient and has serious safety and quality issues. While other industries have surmounted similar challenges by transforming themselves through information technology, healthcare lags behind. Major reasons are that our approaches to care delivery and financial incentives were designed for a bygone era. Beyond that the technology offered to practitioners has often been overly expensive...

Healthcare Information Management Systems, 4th edition, is a comprehensive volume addressing the technical, organizational and management issues confronted by healthcare professionals in the selection, implementation and management of healthcare information systems. With contributions from experts in the field, this book focuses on topics such as strategic planning, turning a plan into reality, implementation, patient-centered technologies, privacy, the new culture of patient safety and th...

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with...

IT in Pharmacy: An Integrated Approach aims to describe and discuss the major areas of pharmacy IT innovation (e-prescribing, drug databases, electronic patient records, clinical decision support, pharmacy management systems, robots and automation etc) from a systems and a professional perspective. It will also consider how the areas of pharmacy IT link together and can be used to enable and develop pharmacy professional practice. The book will examine pharmacy IT from an international per...