RBQM Guide - The Clinical Researcher's Guide to Risk-based quality management

Risk-Based Quality Management (RBQM) - 2nd Edition

The Clinical Researcher’s Guide to RBQM (2nd Edition)

Risk-based quality management (RBQM) applies the principles of risk-based monitoring to the entire clinical trial.

Order Now

Artem Andrianov & Johann Proeve

02 the book

About
The Book

Content

Introduction to RBQM
Understanding Risk in Clinical Trials
Quality Management in a Digital Trial World
Regulatory Framework
Quality management system and E6(R3) alignment
Quality by Design in Clinical Trials
Practical QbD Workshops and Templates
Risk-Based Quality Management Framework
Centralized Monitoring In Practice
Unsupervised Centralized Statistical Monitoring
KRIs, acceptable ranges, and QTLs
Managing Quality Issues, Protocol Deviations, and CAPA
Data and technology architecture for RBQM
AI and ML in risk-based monitoring and QbD
Regulatory & Ethical Considerations for AI in RBQM
Rolling Out QbD and RBQM: Operating Model and Governance
Business case and value realization of RBQM
Maturity models, roadmaps, and pitfalls
Case study – “The QTL we switched off”
Towards self-adaptive quality ecosystems
Future scenarios for RBQM and AI
Conclusion: From projects to practice

Sign up for our free newsletter

Subscribe the RBQM newsletter to get the latest information right to your inbox and don't miss out your bonus benefits!

We promise not to spam you. You can unsubscribe at any time.

What Our Readers Say

The Second Edition is Available

Sales is Launched

Order now

About
The Author

Dr. Artem Andrianov, Ph.D.

Artem Andrianov, Ph.D., is a highly accomplished and experienced professional in the field of clinical data quality and biostatistics. As the CEO of Cyntegrity, he brings over 25 years of expertise to the table, having worked on a wide range of projects in the pharmaceutical industry.

Artem Andrianov holds a Ph.D. in Mathematical Modelling and an Executive Master of Business Administration from Cass Business School. He is committed to pushing the boundaries of RBQM and driving it to new frontiers.

In 2013, Artem Andrianov co-founded Cyntegrity, a company specializing in data-driven risk management in clinical trials. He has been instrumental in the growth and success of the company and continues to lead the way in advancing the field of RBQM.

02 Author

About
The Author

Dr. Johann Proeve, Ph.D.

Johann Proeve has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former international role of VP Global Data Management at Bayer Healthcare.

Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, Johann Proeve is widely regarded as the go-to source for Clinical Data Management and RBQM. In this regard, he has been invited to speak to clinical organizations worldwide, including regulatory bodies, sponsors, and CROs, at conferences like DIA, SCDM, PCT, PharmaForum, and SCOPE.

Johann Proeve holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharmaceutical Medicine program).