Risk-based quality management (RBQM) has become a cornerstone of modern clinical trial execution, helping sponsors proactively manage risk to improve data integrity, patient safety and operational efficiency. Industry adoption continues to improve; data from the Association of Clinical Research Organizations (ACRO) shows that in 2024, 96% of trials incorporated at least one RBM or RBQM component. However, taking the next step requires implementation of a holistic RBQM strategy that relies on fully integrated, cross-functional approaches – and this remains variable across the industry.
This webinar will explore how sponsors can build sustainable RBQM frameworks that move beyond compliance toward measurable, long-term value. Attendees will learn the core elements of successful RBQM strategies, the expanding role and impact of central monitoring and real-world results from a central monitoring assessment case study. The session will also address common implementation challenges and practical approaches for strengthening RBQM through processes tailored to specific study needs.
Register to learn how a mature and intentional RBQM strategy can drive higher quality, more efficient clinical development programs.
Sources:
- Association of Clinical Research Organizations (ACRO). RBQM Landscape Summary Report. June 2025. https://www.acrohealth.org/wp-content/uploads/2025/06/ACRO_2025-RBQM-Report_Final-062425.pdf
Speaker
Dmitri Berman, Vice President, Global Clinical Operations, Premier Research
Dmitri Berman is Vice President of Global Clinical Operations at Premier Research, leading clinical delivery, risk strategy and central monitoring functions. With over 20 years of experience in the clinical research industry, Dmitri has built deep expertise in designing and executing fit-for-purpose risk-based quality management (RBQM) strategies across Phase I–III trials.
Throughout his career, Dmitri has held senior roles at multiple large CROs, helping advance RBQM and centralized monitoring models at scale. He is recognized for his ability to translate risk frameworks into operational solutions by leveraging modern technology platforms, data-driven oversight and cross-functional collaboration to improve quality, efficiency and trial performance.
Dmitri holds a Bachelor’s degree in Biology from the University of Texas at Austin.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited to:
- Drug Development
- Clinical Operations
- Medical Affairs
- Regulatory Affairs
- Project Management
What You Will Learn
Attendees will gain insights into:
- Metrics that support the need for greater adoption of RBQM
- Elements of a successful RBQM strategy
- The value of central monitoring and its evolving role in clinical research
Xtalks Partner
Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more visit premier-research.com.
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