Risk-Based Quality Management (RBQM): The Connective Tissue for Clinical Data Quality

Clinical data quality is not the sole responsibility of any one function—it is a shared commitment that begins well before the first patient is enrolled. So why is risk-based quality management (RBQM) still often viewed as a monitoring-only exercise?

One key reason may be that many RBQM implementations fall short due to fragmented data sources, limited real-time access and a lack of advanced tools to proactively identify and manage risk.

In this webinar, the expert speakers will introduce a more integrated approach—positioning RBQM as the connective tissue of clinical operations.

By breaking down silos and embedding data quality oversight throughout the trial lifecycle, RBQM can become a powerful enabler of both compliance and efficiency. The key topics will include the following:

• A Holistic View of RBQM: Understand how RBQM can be more than just monitoring—it can be a strategic framework integrated across the entire trial process
• Common Barriers to Effective RBQM: Explore how the absence of a single source of truth, real-time data access and advanced analytics limits risk detection and decision-making
• RBQM as a Collaboration Catalyst: Learn how RBQM can foster cross-functional alignment, streamline oversight and support continuous data quality from startup to closeout

Register for this webinar today to discover how a modern, integrated approach to risk-based quality management can transform from a monitoring task into a strategic driver of clinical trial success.

Speakers

Olgica Klindworth, VP, Data Quality and Risk Management Solutions, Medidata

Olgica Klindworth is a Vice President of R&D at Medidata, focusing on Data Quality and Risk Management Technology including development of AI driven data surveillance approaches. Prior to joining Medidata, Olgica spent 17 years at PPD, in data management and RBQM space, spearheading development of Data Analytics and Centralized Monitoring processes and capabilities at PPD.

She has participated in or led a number of data quality, innovation and RBQM initiatives and served as a subject matter expert or speaker in a number of industry conferences. Olgica holds Bachelor of Science in Microbiology from University of Texas at Austin and Master of Science in Analytics from Texas A&M University.

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Anne Rosenberg, Solution Services Principal, Data Quality and Risk Surveillance, Medidata

Anne Rosenberg is a seasoned clinical trial professional with over 20 years of expertise in clinical operations, risk-based quality management (RBQM) and risk surveillance. In her current role as Solution Services Principal at Medidata, Anne leads a team of 15, guiding clients and stakeholders in the implementation and optimization of Medidata’s RBQM solutions. Anne is recognized for her operational excellence and her ability to manage large-scale, multi-country clinical trials.

As an expert in RBQM technology, she collaborates closely with stakeholders to embed best practices and drive innovation in clinical trial oversight and quality management. Anne holds a BA in Anthropology from the University of North Carolina at Chapel Hill and is an advocate for advancing quality management frameworks in clinical research.

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