Your organisation is spending time, money, and resources to ensure trial data quality but what you may find is that current methods can delay risk identification by months, if at all, and it requires your team to know all the potential errors, which is next to impossible.
With traditional data monitoring methods:
- Up to ~80% of edit checks never fire
- Many edit checks that DO fire are closed without the site fixing the problem
- Many errors are never detected and add risk to drug submissions
Ruthie Davi, PhD
Director, Data Science, Medidata Solutions
Ruthie Davi has worked in the area of pharmaceutical product development, and specifically the FDA, over 20 years. In her current position as a Director in Data Science at Medidata Solutions, she is part of a team focused on providing centralized systematic monitoring and other novel clinical trial tools.
Ruthie has held numerous positions within the FDA, including Statistical Reviewer, Team Leader, and Deputy Director, where she implemented innovative statistical methods and made recommendations for clinical trial designs tailored to the regulatory setting. She has conducted the statistical review, represented the Agency at Advisory Committee meetings, and provided recommendations regarding FDA marketing approval for numerous New Drug and Biologic Licensing Applications.
With a particular interest in pediatric clinical trials, she was an active member of FDA's Pediatric Review Committee. Ruthie holds a Ph.D. in biostatistics from George Washington University.
Ruthie Davi, PhD
Managing Director, Strategic Monitoring
Kyle Given is a Vice President within Medidata's Strategic Consulting team. His current organization supports the implementation of transformational business solutions that leverage technologies and advanced data analytics.
With over 20 years experience in clinical research, Kyle is a recognized expert in operational efficiency models. Prior to joining Medidata, Kyle was Executive Vice President at Research Pharmaceutical Services (RPS). During his tenure with RPS he worked alongside leading large and mid-sized pharmaceutical companies to design, implement and enhance global site management and monitoring.
Stacey Yount
Principa Principal, Data and Analytics Consulting
With over 19 years in clinical research, Stacey has experience in clinical data management, clinical operations, statistics, CROs, and central laboratories.
Prior to joining Medidata in 2015, she was with Covance for 5 years and Eli Lilly for 10 years. Stacey held several leadership positions at Covance, including the Vice President of Project Management, Data Management, and Alliance Management.
- What the new ICH E6 (R2) guidelines mean for you
- Analysis of how and where companies waste time, money, and resources on edit checks
- A new approach to improve data quality, risk reduction, and increased productivity
- What the convergence of centralised monitoring and data management can mean for your organisation
- Head of Data Management
- Head of Data Quality
- Head of Clinical Operations
- Data Manager
- Head of BioStats
- Biostatistician
- Head of Monitoring
- Clinical Research Associate
- Site Monitors
- Clinical Operations Associate
