Traditional monitoring strategies, such as source data review (SDR) and source data verification (SDV), have long been the cornerstone of ensuring clinical trial data quality.
While effective in the past, these methods are resource-intensive, costly and do little to improve data quality. With advancements in technology and data analytics, centralized monitoring has emerged as a key contributor to monitoring, allowing for significantly reduced SDR and SDV sampling strategies.
Centralized monitoring, a key component of risk-based quality management (RBQM), offers a broader and more comprehensive view of trial data, enabling faster deviation identification and reducing monitoring costs by up to 20 percent. Despite its potential to optimize clinical trials significantly, the industry has been slow to adopt centralized monitoring and shift away from traditional approaches like SDR and SDV.
The expert speakers will examine the limitations of traditional methods, the benefits of transitioning to centralized monitoring and why this innovative approach should become the new standard for driving clinical trial excellence.
Join this insightful webinar to explore the evolution of monitoring strategies in clinical research.
Speaker
Nicole Stansbury, Senior Vice President, Global Clinical Operations, Premier Research
Nicole Stansbury, Senior Vice President, Global Clinical Operations, is responsible for oversight of clinical operations, which includes clinical strategy and delivery, study start-up, central monitoring, site management and risk-based monitoring at Premier Research. She leverages an innovative, data-driven approach and more than 25 years of industry experience to help sponsors address the rapidly evolving demands of the clinical development industry. In her role, Stansbury is focused on finding ways to simplify process and improve technology adoption to decrease the time, cost, complexity and risk of delivering clinical research.
Prior to joining Premier Research, Stansbury held various CRO leadership positions where she was instrumental in the strategic implementation of risk-based monitoring, central monitoring and continuous improvement of clinical operations processes. Stansbury has been co-lead for the Association of Clinical Research Organizations Risk-Based Monitoring (ACRO RBM) Working Group working with TransCelerate and the FDA since 2014. She holds a Bachelor of Science from Texas A&M and a Lean Six Sigma – Yellow Belt certification.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:
- Drug development
- Clinical operations
- Medical affairs/Regulatory affairs
- Project management
What You Will Learn
Attendees will learn about:
- SDR and SDV sampling strategies
- Limitations of using a traditional monitoring approach
- Benefits of executing centralized monitoring
Xtalks Partner
Premier Research
Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.
Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.
As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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