mindsON RBQM | Special Edition - The Cost Optimization Power of RBQM: Backed by Data

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Moderators

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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, units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at: www.academy.cyntegrity.com

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Anastasia Shapovalova 

(Head of Centralized Monitoring & Analytics at Cyntegrity) 

Anastasia, a recognized leader with over 20 years in pharmaceutical operations and business development, brings deep insights from her broad experience with major companies such as GSK, Pfizer, Eli Lilly and Cyntegrity. Renowned for her expertise in business analytics and strategic planning, she's driven growth and efficiency, honing her proficiency in Clinical Trial Risk Management. Her noteworthy accomplishments at Cyntegrity, including leading projects in clinical trials fieldwork, risk analytics, and central monitoring, underscore her comprehension of risk management, operational efficiency, and SDV reduction.

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Sven Cohadzic 

(Project Manager at Cyntegrity)

Sven, an accomplished professional in International Business and Qualitative Finance, transitioned into life sciences through his critical role as a Clinical Product Manager at Cyntegrity. His insightful strategies in data-intensive marketing and the development of open data visualizers have fortified his role within the industry. Currently managing the MyRBQM system for clinical trials at Cyntegrity's Project Management Office, Sven’s expertise in business, technology, and data analysis significantly drives the progress in Risk-based Quality Management for Clinical Trials. His key contributions consistently bolster risk management and operational efficiency.

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Julien Nunes-Goncalves

(RBQM Solutions Architect at Cyntegrity)

Julien, a scientist with 6 years of experience in pre-clinical and clinical research, leverages his solid scientific foundation in distinct roles within marketing and business development in the healthcare and life science industries. Effectively communicating scientific content for impactful results, Julien successfully overcomes the common misalignments between sales and marketing teams. As Cyntegrity’s RBQM Solutions Architect, he adeptly translates client needs into actionable RBQM solutions tailored to each organization. With his combination of scientific training and marketing acumen, he significantly contributes to Risk-based Quality Management within Clinical Trials.

September 11, 2023 Lauren Wendland

Excellent workshop. Thank you! The example of under-reporting AEs was particularly helpful as it is something we have been working to address. I am also very interested to start working with the DIGR approach.

March 28, 2024 Susan Andersen

I really appreciated the way the webinar was structured, to provide the background, followed by working thru real world examples. I look forward to future sessions where we continue the example.

April 25, 2024 Philip Calvillo

Very helpful webinar to introduce me to the world of AI for use in Clinical research QRBM. This was very relevant, and Keith and Johann are the best! Thanks.

Description

Join us for a quantitative exploration of risk-based clinical trials, a game-changer in Clinical Trial Risk Management. Throughout this webinar, we'll demonstrate how applying a risk-based approach can help save remarkably in different areas such as Risk Management Study Conduct, Operational Efficiency, SDV Reduction, and Protocol Amendments, leading to an average savings of $2.8M per study.

You'll discover how risk-based quality management (RBQM) has the potential to save up to $15M in the Risk Management Market. Backed by real-world data, we'll demonstrate the quantitative benefits of RBQM and even take you through our unique SDV reduction calculator, which provides you with tangible insights to boost your clinical trial operations.

For a future where we balance AI technology with practicality, join us as we illustrate how Integrated RBQM can yield substantial savings, increase compliance, and streamline your processes. All backed by numbers, all in this exclusive webinar.

In this special mindsON edition, our distinguished speakers, Anastasia, Sven, and Julien, will provide you with their expert insights into risk-based clinical trials. With their extensive combined experience spanning pharmaceutical operations, international business, clinical product management, and physiological science, they stand at the forefront of Clinical Trial Risk Management.

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 dialogue 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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