mindsON Centralized Statistical Monitoring | Episode 1 - How to use a CSM tool; Numeric data

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Appointment

September 19, 2022, 3:00 PM - 4:00 PM

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Moderators

MyRBQM Academy by Cyntegrity

Targeted education helps clinical research teams embrace the implementation process and contribute to its success ensuring your organization’s RBQM strategy has the components it needs to meet regulatory expectations.

Established in 2019, Cyntegrity’s MyRBQM® Academy, unites first-level online education, comprehensive instructor-led training and practical case study workshops. Learn more at: www.cyntegrity.com

Dr. Johann Proeve

Johann Proeve has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.

Ting-Yu Ho

After completing his MSc in Bioinformatics at the Goethe Uni in Frankfurt, Ting-Yu finished his Master’s Thesis with a focus on Machine Learning, computer vision, and biostatistics in Switzerland and joined Cyntegrity afterward as Clinical Data Scientist. His fields of expertise are method development based on clustering and vector similarity calculation, development of risk recommendation systems, and data preprocessing. Ting-Yu engages clinical researchers with his insightful demos of CSM technology.

July 1, 2021 William Clay

This was a great way to refresh the concepts from the My RBQM Green & Black Belt courses. Also, a good discussion of external factors that influence the data.

January 21, 2022 Jan Van Parijs

Great illustration of an extremely useful concept, with well-chosen practical examples that supplement and demonstrate the speaker's vast experience in clinical research and in applying RBM in practice. Combined with excellent "training" and explanation of "value added" process developed for MyRBQM.

April 6, 2022 Stacey Dudkowski

This was the first Webinar I have attended with you, but have registered for others. The content, dialogue, interactions and feedback were excellent.

Appointments

September 19, 2022, 3:00 PM - 4:00 PM

Description

Part 1: Centralized statistical monitoring (CSM) is a way to look at data to detect any abnormalities and risks that were unexpected and unlikely detected via KRIs. What type of data are needed for such an analysis and what is it one can expect to detect? Is it only outliers or can CSM deliver more? What are the appropriate steps to take once abnormal data have been detected? We will demonstrate what such a CSM functionality can provide to the study data quality and the patient safety.

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About "mindsON RBQM" workshops: mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialog and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.

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