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

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.