Wednesday, June 26 • 2:00pm - 3:15pm
#365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-689-L04-P; CME 1.25; IACET 1.25; RN 1.25

The abundance of data collected in clinical research offers an increasing opportunity for insights into risks, quality, and compliance.To realize the full value, the data must be harnessed in a manner that is useful and meaningful, which can be a challenge. The key lies in developing analytics and models that provide insights. Leveraging data is particularly valuable in an environment where Risk Based Monitoring (RBM) is now the norm and the models and dashboards derived from analytics can proactively indicate risks and issues. Interpretation can drive compliance and quality decision making and a focus on what matters most. Advanced analytics and machine learning can also be leveraged to detect irregularities that may indicate falsification and misconduct.

This session will explore the potential of data analytics and modeling as applied to risk-based monitoring activities as well as quality assurance oversight of risk-base monitoring.

Learning Objectives

Design an innovative and efficient sampling SDV method reflecting trends of data error occurrence; Assess how measured risk changes over time, comparing change in risk relative to operational attributes, and judging the effects of risk-based monitoringon risk mitigation; Define key changes to risk-based monitoring programs that may require changes to quality assurance oversight, including audit programs; Discuss how site audits may shift focus from on-site audit activities to remote.


Matthew Krumrai


Statistical Models of Risk Flux Reveal Dynamics of Risk-Based Monitoring Managed Clinical Trials
Kristin Stallcup, MS, PMP

Study on Designing a Method of Sampling SDV in a Clinical Trial Using Audit Trail Data
Yuhi Sakajiri

Subject Data Analysis and Potential Fraud and Misconduct Analysis for Data Quality in Clinical Trials
Wei Xue, DrPH

Maintaining Quality Assurance in a Risk-Based Monitoring Environment
Matthew Krumrai

avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →
avatar for Yuhi Sakajiri

Yuhi Sakajiri

Student, Waseda University
Yuhi Sakajiri (born in Chiba, Japan, in May. 1995) received B.Eng. degrees in Industrial and Management Systems Engineering from the Waseda University, Japan, in 2018. Since 2018, he engaged in quality management research at the university's M.Eng. course. His research interest is... Read More →
avatar for Kristin Stallcup

Kristin Stallcup

Senior Director, Covance
Kristin Stallcup brings 15 years of industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of the Xcellerate Informatics suite into business process. Previously she served in central monitoring... Read More →

Wei Xue

Centralized Monitoring Manager, IQVIA
Wei Xue is a Centralized Monitoring Manager in Data Trial Execution in IQVIA. Her expertise spans in statistical and machine learning analysis in risk-based monitoring, predictive analysis and potential fraud and misconduct analysis in clinical trials industry. Wei got her Doctor... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA