Risk-Based Quality Management: The Ultimate Clinical Researcher’s Guide

Gain a thorough understanding of Risk Based Quality Management with “RBQM: Practical Guide for Clinical Research Professionals,” an essential resource for mastering practical applications in clinical research.

Overview

Risk-Based Quality Management in Clinical Trials: The Clinical Researcher’s Guide.

This book essential for navigating modern clinical trials. It delves into Risk-Based Quality Management (RBQM), a globally endorsed methodology that enhances data quality and integrity, leading to more reliable outcomes and faster product development. The book incorporates ICH E6 R2, upcoming R3 updates, and key elements from ICH E8, offering a comprehensive view of quality management throughout clinical trials. It covers foundational RBQM principles with clear examples and real-world case studies, making it accessible for various clinical research professionals. This guide equips you with the knowledge and tools to implement effective RBQM strategies, transforming risks into actionable insights for predictable success.

This book provides essential knowledge for implementing Risk-Based Quality Management (RBQM) in clinical research.
It offers practical insights and strategies to enhance the efficiency and effectiveness of clinical trials.
The guide helps professionals stay compliant with regulatory requirements and industry standards.
It equips researchers with tools to identify and mitigate risks, ensuring higher quality data.
The book serves as a comprehensive resource for both novice and experienced clinical research professionals.

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. His academic background includes a Ph.D. in Mathematical Modelling and an Executive MBA.

Dr. Andrianov co-founded Cyntegrity in 2013, focusing on advancing RBQM. His specialized knowledge spans Spirometry, ECG, Oncology, ePROs, and clinical data management. Committed to making clinical trials safer and more reliable, Dr. Andrianov is a key figure in the evolution of RBQM.

Johann Proeve, PhD | Johann Proeve boasts over 40 years of experience in the biopharmaceutical industry, primarily serving as VP of Global Data Management at Bayer Healthcare. Recognized as one of the 2018 MCC Champions by the Metrics Champion Consortium and awarded ‘best presentation on RBQM’ at the 2024 PHUSE Connect conference, Johann is esteemed for his expertise in Clinical Data Management and RBQM. His extensive experience has made him a sought-after speaker at global conferences, including DIA, SCDM, PCT, PharmaForum, and SCOPE, where he addresses regulatory bodies, sponsors, and CROs.

Known for his relatable approach, Johann offers practical management strategies that help study teams identify critical processes and data, assess risks, and allocate monitoring resources effectively. His thought leadership articles have been featured in prestigious publications like ACT, Contemporary Clinical Trials, and BMC Medical Research Methodology. Johann holds a Ph.D. in Zoology/Animal Biology and currently lectures at the University of Essen Duisburg in the MSc in Pharmaceutical Medicine program.