The Guide to Ensuring the Quality and Integrity of Clinical Trials

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Risk-Based Quality Management

The Clinical Researcher’s Guide to RBQM

Risk-based quality management (RBQM) takes the principles of risk-based monitoring and applies them to the entirety of a clinical trial.

Artem Andrianov & Johann Proeve

01 the book

The Book


  1. Introduction
  2. Fundamentals of Risk and Quality Management
  3. Regulatory Framework
  4. Risk-Based Quality Management in Pharma Product Development
  5. Quality by Design & Quality Management System
  6. Quality risk management in a QMS
  7. Risk-Based Quality Auditing and Inspections
  8. Operational plan of rolling out of QbD and RBQM in a Pharma Organization
  9. Cost Optimization Potential in Clinical Operations with RBQM approach
  10. Risk Management in Clinical Trials
  11. Handling Quality Issues and Deviations
  12. Options for an RBQM organization
  13. Future Trends and Challenges in Risk-Based Quality Management
  14. Conclusion

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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

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).


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Quality by Design & Quality Management System In modern pharmaceutical development, the concepts of Quality by...

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