An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.

Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.

An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.

A concise and accessible overview of the design, implementation and management of medical software.

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!

Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development. - Presents a comprehensive overview on clinical trials and drug development challenges in acute neuroscience populations - Provides neurologists, neuroscientists and drug developers with a complete understanding of scientific and medical issues related to designing clinical trials - Edited by leaders in the field who have designed and managed over 50 neuroemergency clinical trials

Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into 'building blocks' that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry. - Uses practice-based evidence for developing and delivering quality assurance and management systems - Includes case studies associated with 'failures' and 'lessons learned' - Discusses clinical trials in academic, clinical and industry settings - Demonstrates how to build resilience into systems that could evolve to promote best practices, even with limited resources - Compares and contrasts different QA/QC practices