Dr. Artem Andrianov, CEO & Founder of Cyntegrity and renowned expert in risk-based quality management, joins forces with Dr. Johann Proeve, former VP of Global Data Management at Bayer Healthcare, to release "Risk-Based Quality Management: Guide for Clinical Research Professionals." This comprehensive guide distills their extensive experience into practical strategies for implementing RBQM in clinical trials, emphasizing quality and data integrity. Now available on Amazon in Kindle format, with a hardcover edition forthcoming, this book is an invaluable resource for clinical research professionals seeking to navigate and excel in the complex landscape of modern clinical trials.
About the Book
"Risk-Based Quality Management in Clinical Trials: The Clinical Researcher's Guide" is an essential resource for professionals navigating the complexities of modern clinical trials. This guide explores Risk-Based Quality Management (RBQM), a globally endorsed methodology that enhances the quality and integrity of clinical data, ensuring more reliable outcomes and expedited product development.
The book incorporates the details of ICH E6 R2 and the forthcoming R3 updates, along with key elements from ICH E8. It presents a holistic view of quality management in clinical research, ensuring a comprehensive approach to quality considerations throughout the lifecycle of clinical trials.
Structured for clarity and accessibility, the guide covers foundational RBQM principles such as risk identification, evaluation, control, and communication. It integrates rich examples and real-world case studies from diverse therapeutic areas, illustrating the practical application of these strategies.
Key Insight
Since 2013, Artem Andrianov and Johann Proeve have been recognized as thought leaders in the field of RBQM. They have been at the forefront of the evolution of RBQM and Quality by Design (QbD) methodologies, transitioning from Risk-Based Monitoring to the current integrated RBQM approach. Through their work at Cyntegrity, they have successfully translated theoretical guidelines into practical, applicable processes for everyday use. Additionally, as instructors at the MyRBQM Academy, they have adeptly converted theoretical use cases into real-world applications, making significant contributions to the field. They know the ins and outs and can pinpoint the dos and don'ts. Learn from the experts.
Who Should Read This Book?
Whether you are a clinical research associate, project manager, central monitor, study manager, clinical data manager, statistician, or regulatory professional, this book equips you with the comprehensive knowledge and tools needed to implement an effective RBQM strategy. By systematically managing risks, you can turn potential challenges into distinct advantages for clinical research endeavors.
Dr. Artem Andrianov: "Our goal with this book is to provide clinical research professionals with a robust framework for managing risks, ensuring that the quality and integrity of clinical data are maintained at the highest standards."
Dr. Johann Proeve: "Risk-Based Quality Management is not just about compliance; it's about transforming potential challenges into actionable insights that drive the success of clinical trials."
About the Authors
Artem Andrianov, PhD With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. Dr. Andrianov holds a Ph.D. in Mathematical Modelling and an Executive MBA. He co-founded Cyntegrity in 2013, focusing on advancing RBQM. His expertise spans Spirometry, ECG, Oncology, ePROs, and clinical data management.
Johann Proeve, PhD Dr. Johann Proeve has over 40 years of experience in the biopharmaceutical industry, primarily as the former VP of Global Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium and recognized for the best presentation on RBQM at the 2024 PHUSE Connect conference, Johann Proeve is a renowned expert in Clinical Data Management and RBQM. He holds a Ph.D. in Zoology/Animal Biology and currently lectures at the University of Essen Duisburg. Johann is also a partner and the Chief Scientific Officer at Cyntegrity.
Availability
"Risk-Based Quality Management: Guide for Clinical Research Professionals (English Edition)" is now available on Amazon. A hardcover version will be available soon.
For more information, please visit: RBQM.com
About the Book
"Risk-Based Quality Management in Clinical Trials: The Clinical Researcher's Guide" is an essential resource for professionals navigating the complexities of modern clinical trials. This guide explores Risk-Based Quality Management (RBQM), a globally endorsed methodology that enhances the quality and integrity of clinical data, ensuring more reliable outcomes and expedited product development.
The book incorporates the details of ICH E6 R2 and the forthcoming R3 updates, along with key elements from ICH E8. It presents a holistic view of quality management in clinical research, ensuring a comprehensive approach to quality considerations throughout the lifecycle of clinical trials.
Structured for clarity and accessibility, the guide covers foundational RBQM principles such as risk identification, evaluation, control, and communication. It integrates rich examples and real-world case studies from diverse therapeutic areas, illustrating the practical application of these strategies.
Key Insight
Since 2013, Artem Andrianov and Johann Proeve have been recognized as thought leaders in the field of RBQM. They have been at the forefront of the evolution of RBQM and Quality by Design (QbD) methodologies, transitioning from Risk-Based Monitoring to the current integrated RBQM approach. Through their work at Cyntegrity, they have successfully translated theoretical guidelines into practical, applicable processes for everyday use. Additionally, as instructors at the MyRBQM Academy, they have adeptly converted theoretical use cases into real-world applications, making significant contributions to the field. They know the ins and outs and can pinpoint the dos and don'ts. Learn from the experts.
Who Should Read This Book?
Whether you are a clinical research associate, project manager, central monitor, study manager, clinical data manager, statistician, or regulatory professional, this book equips you with the comprehensive knowledge and tools needed to implement an effective RBQM strategy. By systematically managing risks, you can turn potential challenges into distinct advantages for clinical research endeavors.
Dr. Artem Andrianov: "Our goal with this book is to provide clinical research professionals with a robust framework for managing risks, ensuring that the quality and integrity of clinical data are maintained at the highest standards."
Dr. Johann Proeve: "Risk-Based Quality Management is not just about compliance; it's about transforming potential challenges into actionable insights that drive the success of clinical trials."
About the Authors
Artem Andrianov, PhD With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. Dr. Andrianov holds a Ph.D. in Mathematical Modelling and an Executive MBA. He co-founded Cyntegrity in 2013, focusing on advancing RBQM. His expertise spans Spirometry, ECG, Oncology, ePROs, and clinical data management.
Johann Proeve, PhD Dr. Johann Proeve has over 40 years of experience in the biopharmaceutical industry, primarily as the former VP of Global Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium and recognized for the best presentation on RBQM at the 2024 PHUSE Connect conference, Johann Proeve is a renowned expert in Clinical Data Management and RBQM. He holds a Ph.D. in Zoology/Animal Biology and currently lectures at the University of Essen Duisburg. Johann is also a partner and the Chief Scientific Officer at Cyntegrity.
Availability
"Risk-Based Quality Management: Guide for Clinical Research Professionals (English Edition)" is now available on Amazon. A hardcover version will be available soon.
For more information, please visit: RBQM.com
