CONFERENCE PRESENTATION · SCDM 2024 EMEA Leadership Forum & Conference
Transforming Trials with RBQM as the Connective Tissue for Data Quality
- Session Type: Panel Discussion
- Topics: Risk-Based CDM, Soft Skills including Leadership & Executive Skills, Clinical Data Competencies & Cross-Functional Interactions
- Session Level: Intermediate
Overview
Ensuring clinical data quality is a cross-functional responsibility that starts well before enrolling the first patient. However, the perception of RBQM as a monitoring or standalone exercise limits its potential impact. This narrow view often stems from the absence of a holistic data strategy and a genuinely data-driven culture, resulting in a fragmented ecosystem marked by data and workflow silos and increased overhead. While innovative approaches like AI-driven task automation and historical data insights can enhance RBQM frameworks, their effectiveness hinges on being accessible to all stakeholders overseeing data quality.
Ultimately, successful outcomes require a more holistic approach that challenges role definitions and established ways of working and provides access to more sophisticated tools. We have identified a panel of industry experts involved in data management and clinical operation initiatives who are adopting this new approach. We will discuss how RBQM principles can serve as the connective tissue between roles responsible for data, site, patient, and risk monitoring, seamlessly weaving data quality oversight into the DNA of the trial's lifecycle.
What You'll Learn
- Understand the challenges hindering broader adoption of RBQM by data management groups and the impact resulting from implementation complexities.
- Learn how different organizations have embraced a data-driven culture to empower teams with greater foresight when making decisions.
- Discuss strategies for simplifying the adoption of RBQM approaches with the help of unified data and appropriate application of technology.
Meet the Presenters
Olgica Klindworth
Vice President for Data Quality and Risk Management
Medidata
Olgica Klindworth is Vice President for Data Quality and Risk Management at Medidata, where she focuses on developing Data Quality solutions, including creating AI-driven data surveillance approaches. Before joining Medidata, Olgica dedicated 17 years to PPD, with a decade spent in data management leadership roles. During her tenure, she built Data Management capabilities and supervised the execution of numerous clinical trials spanning various therapeutic areas. Olgica also played a pivotal role in driving the development of Data Analytics and Centralized Monitoring processes and capabilities at PPD. Olgica holds a Bachelor of Science degree in Microbiology from the University of Texas at Austin and a Master of Science degree in Analytics from Texas A&M University.
Medidata
Genevieve Nadeau
Head of RBQM & Clinical Operations UK
Orion Corporation
Geneviève Nadeau has held a variety of roles in the pharmaceutical industry over the last 20 years. With a strong background in technology, project & change management, clinical research and a passion for data sciences, Gen has found an affinity for the emerging RBQM discipline.
Orion Corporation
As Head of RBQM & Clinical Operations UK, Gen has leadership responsibility in implementing RBQM methodologies in all Clinical Trials sponsored by Orion Pharma. Making RBQM methodologies accessible across the organisation and thereby achieving its full potential is Gen’s main goal as Head of RBQM & Clinical Operations UK.
Miguel Valenzuela
Associate Director Clinical Operations RBQM+
Alnylam
Having been in the industry for over 20 years, Miguel has worked in various capacities in informatics, Clinical Operations, and Quality Assurance. In his earlier most recent roles at Bayer and Roche, Miguel has led Quality Risk Management, Risk-Based Monitoring, analytics-driven oversight, and continuous improvement groups and programs.
Alnylam
Since 2019, Miguel has led the development and implementation of the Risk Based Quality Management (RBQM+) approach in Alnylam. Currently, he is Associate Director of Clinical Operations RBQM+ and continues to lead the RBQM+ process and tool implementation, as well as the buildup of the RBQM+ team.
Elena Zaffaroni
Sr Director Clinical Risk Management
ICON
Clinical Research professional - central monitoring and risk based quality management expert
ICON
Earn CEUs
SCDM is authorized by IACET to offer 0.1 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
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