CONFERENCE PRESENTATION · SCDM 2024 EMEA Leadership Forum & Conference
From One-Size-Fits-All to Risk Proportionate Clinical Data Quality Approach - Shifting Gears with RBQM
- Session Type: Storytelling
- Topics: Risk-Based CDM, Soft Skills including Leadership & Executive Skills, Clinical Data Competencies & Cross-Functional Interactions
- Session Level: Intermediate
Overview
For many years Regulators have been steering us to focus on activities essential to the study, and to eliminate non-essential activities. So far, a risk-based approach in clinical development predominantly focussed on risk-based monitoring, where the effort was aligned with the added value, and where a reduced source data verification (SDV) of the critical data became generally accepted.
Following pivotal changes in ICH GCP requirements, introducing specifically Data Governance to recognize the increasing role of data in clinical trials along with the use of technology to collect, maintain, and analyse data our Clinical Data Management efforts are going to focus on activities essential to the study, and to limit non-essential activities. Including the Clinical Data Management area in the risk-proportionate approach during execution and oversight of clinical trials will complement the diversification of monitoring methods and risk-based review of the data will be used the same way as the reduced source data management (SDV). Risk Based Data Management (RBDM) will be based on establishing an overarching comprehensive approach, which is leveraging cross-functional risk assessment, technology, adaptive monitoring and combining all data and data stakeholder performance in Centralised Monitoring activities to ensure data quality, integrity, and subject safety.
With the growing diversity of data sources in clinical trials and the growing amount of non-EDC data, we need to extend our focus on Critical to Quality (CtQ) and Critical Data and Processes from risk-based site monitoring to risk-based data monitoring, including the clinical vendors to complement the E2E risk proportionate data validation approach.
What You'll Learn
- Share concepts & developments to illustrate the RBQM in CDM implementation by three concrete use cases coming from 3 sponsor companies
- Show how we are approaching the paradigm shift in data cleaning of eCRF data, cleaning of external data, and the set-up of a Centralized Data Monitoring model in a hybrid operating model
- Inspire some of our CDM colleagues in RBQM implementation and hear a some feedback
Meet the Presenters
Joanna Florek-Marwitz
Head Risk Management & Data Quality
UCB BIOSCIENCES GmbH
Joanna brings over 20 years of managerial and technical experience in clinical research industry delivering business and clinical data transformation solutions. She has extensive experience in clinical and non-interventional trials operations across all therapeutic areas and is an expert in applying program management, integrated risk-based data and quality management, process improvement, standardization, innovation, and change management methodologies.
UCB BIOSCIENCES GmbH
Joanna has led many large-scale, global initiatives within the pharmaceutical industry that include clinical data management and analytics, process optimization and technology improvements, driving operational efficiencies and working relationship with customers for operational service excellence.
Her technical experience, background in analytics and process improvement brings critical value to technology implementation ensuring trial execution for patient safety and reliable data to answer the trial scientific questions.
Guy Bafort
Head of Central Data Monitoring
Merck Healthcare KGaA
Guy is currently deploying the Centralized Data Monitoring capability at Merck Healthcare KGaA. In doing so, he brings several years of Risk Management and Central Monitoring as well as Centralized Data Review expertise to the table. He also is the business process owner for all data management processes in his current organization.
Merck Healthcare KGaA
But his true strenghts lie within his versatility as he has a career that spans over Clinical Operations, Central Monitoring, Data Review, Vendor Management and even Regulatory Compliance. This allows him to understand the varying expectations from a broad range of stakeholders and enabled him to act as a connector in an ever more complex environment that clinical research is these days.
Guy holds a Master´s degree in Speech Therapy and Audiology and a Bachelor´s degree in Medical Sciences, both from the University of Gent, Belgium.
Peter Stokman
Business Lead Data Review & Visualization
Bayer
Biologist/pharmacolgist by training; 35+ years of experience in pharma - both government & industry. Last 20 years in Clinical Data Management in senior leadership roles in big pharma. Last 10 years geared towards change management, particularly related to the development & implementation of risk-based approached & centralized monitoring in data quality management.
Bayer
Christine Goffe
Team Lead Centralized Monitoring
UCB
Passionate about sciences and technologies, I studied Bio-Engineering at the Catholic University of Louvain (UCL) in Belgium. After several years in Clinical Data Management in an academic environment, I joined UCB in 2012 as a training manager for Global Quality Assurance and Patient Safety departments. I then joined the Risk Management and Data Quality team when the department was created in 2016. My first role in the team was Study Data Risk Manager (SDRM) and then I took the lead of the SDRM team at the end of 2020. Our team is responsible for Data Surveillance Oversight activities, using Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) and data visualization tools to detect data anomalies and trends at study, site, study participant level in a timely manner. The output of Data Surveillance Oversight activities also influence third party vendor selection and operational oversight activities.
UCB
My areas of expertise are centralized monitoring strategy and data surveillance oversight.
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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