CONFERENCE PRESENTATION · SCDM 2024 EMEA Leadership Forum & Conference
Synergizing Data Strategy and RBQM in Data Management: A Collaborative Imperative
- Session Type: Storytelling
- Topics: RBQM as a Holistic Clinical Trial Approach
Overview
In the rapidly evolving landscape of data management, the emphasis on data strategy and Risk-Based Quality Management (RBQM) has become paramount. This session aims to explore the relationship between these two critical workstreams, emphasizing that neither can exist in isolation and be successful . We will delve into the following 3 key aspects:
1. Data Strategy for Fit-for-Purpose Data: The cornerstone of effective data strategy lies in ensuring that the data is not only fit for purpose but also consistent, reliable, and repeatable. This segment will explore how a well-crafted data strategy lays the foundation for high-quality data that meets specific business needs while maintaining integrity and reproducibility.
2. RBQM in Data Management: The focus here is on the application of RBQM principles in the realm of data management. RBQM demands data that is fit for purpose and consistent, allowing for a robust assessment of its reliability. We will discuss how RBQM frameworks guide the identification, evaluation, and mitigation of risks associated with data quality and integrity.
3. Interdependence and Collaboration: Highlighting the symbiotic relationship between data management and RBQM in data strategy area, this section will emphasize the necessity for strong collaboration between these domains. The interplay between creating a robust data strategy and implementing effective RBQM practices is crucial for the overall success of data management initiatives.
The whole session will be a series of short presentations covering all three above aspects. These presentations will include real-world testimonials and case studies, illustrating how the integration of data strategy and RBQM principles leads to enhanced data quality, improved decision-making, and operational efficiency, Attendees will leave with insights into how these workstreams can be effectively aligned to foster a more robust, efficient, and reliable data management ecosystem.
Meet the Presenters
Agata Zielak
Director, Central Monitoring
GSK
15 years of experience in clinical operation across many functions, 3 years in RBQM space.
GSK
Previously several years of scientific experience in academia: PhD in Biochemistry after graduating Pharmacy and Biotechnology.
Area of interest: Building and development of highly functioning clinops Teams with quality by design/ data analytics/ scientific mindset to foster successful RBQM implementation across the studies and assets.
Jan Poleszczuk
Co-Founder & CTO
CliniNote
A mathematician and biomedical engineer with extensive experience in constructing models and tools for medicine. He has dedicated many years to advanced data analytics in healthcare. His expertise spans individual hospital operations to national healthcare systems.
CliniNote
As the co-founder, CTO, and chief system architect of the startup CliniNote, he spearheads the development of innovative tools that empower doctors and hospitals to generate high-quality medical data.
Within the Institute of Biocybernetics and Biomedical Engineering, Maciej Nałęcz leads a team focused on mathematical modeling of physiological processes.
Tomas Machulka
Manager
Premier Research
Tomas Machulka is Manager at Clinical Data Sciences with Premier Research and has over a decade of experience in Clinical Data Management across the CRO, Pharma industry and Academia. He is known for his quality-oriented approach in managing complex studies while ensuring compliance with regulatory requirements and industry standards. Always seeking innovative solutions, he is dedicated to improving processes through the use of cutting-edge technology and agile methodologies.
Premier Research
Agata Leszczyńska
Central Monitoring Lead
GSK
Clinical reserach professional with strong background in science and extensive experience in different aspects of clinical development, including Data Management, Clinical IT Business Analysis and RBQM, in various therapeutic areas. Former member of TransCelerate QMS Risk Management team. External Expert Evaluator for scientific research proposal at European Commission. As part of scientific work, currently exploring different RBQM methods and tools.
GSK
In the current role as Central Monitoring Lead driving the implementation of Risk Based Quality Management across studies, with a focus on Centralized Monitoring and Data Analytics to ensure consistent application of RBQM principles. Accountable for defining Central Monitoring and Data Analytics strategy on program and study level as well as its set up and execution to enable timely quality study and program delivery.
Paulina Sakowska
Associate Director, Risk Based Quality Management
AstraZeneca Pharma Poland
Paulina Sakowska, proffessional with 7 years of experience in clinical trials. Currently holds the position of Associate Director, Risk Based Quality Management in the Centralized Monitoring Team at AstraZeneca Poland. Previously working as Associate Director, Study Data Manager in the Data Management department.
AstraZeneca Pharma Poland
Carol Schaffer
Director, Program Lead
Pfizer
Carol Schaffer is a Director, Program Lead in the Vaccines therapeutic area, Clinical Data Sciences department at Pfizer. She has over 30 years of experience in the biopharmaceutical industry, starting as a research protein biochemist and moving into the Clinical Data Management discipline in 2000. She has experience in both Early and Late Phase clinical development, both in project and people management. Her therapeutic areas of experience are in Cardiovascular/Metabolism, Inflammation, Immunology, Infectious Diseases, Rare Diseases, Ophthalmology and Vaccines. Carol has expertise in project and vendor oversight as well as global team leadership and governance. Carol holds both Bachelor’s and Master’s degrees in Biology (specializing in Biotechnology) from William Paterson University. Carol has been happily married for over 30 years and has 2 boys: 27 (also a clinical data manager) and 25 (a semi-pro soccer player) and 2 dogs (being dogs). In her free time, she enjoys being outdoors hiking, biking, kayaking and paddle boarding and is a coach for Special Olympics of NJ and a Young Life Capernaum Leader, a ministry for youth with intellectual and developmental disabilities.
Pfizer
Earn CEUs
SCDM is authorized by IACET to offer 0.2 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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