In response to the growing interest in combining onsite and centralized monitoring approaches, we are excited to have Dr. Yuriy Lebed, CEO of Pharmaxi LLC, a Ukraine-based CRO, along with our CEO, Artem Andrianov, Ph.D., to discuss the latest thinking, examine the challenges organizations encounter in integrating these monitoring methods, and provide practical solutions to overcome these obstacles. In this 90-minute interactive workshop, you'll have the opportunity to engage with key topics surrounding onsite and centralized monitoring, such as:
• New FDA Guidance: A risk-based approach to monitoring of clinical investigations (Q&A)
• Latest trends and insights on combining onsite and centralized monitoring in clinical trials
• Understanding the challenges in implementing both monitoring approaches
• Practical strategies to address onsite and centralized monitoring-related difficulties
Chapters:
0:00 Webinar Introduction
0:55 Speakers Introduction
2:54 Agenda
6:49 FDA Guidance: Risk-Based Approach to Monitoring
13:22 Fraud & Misconduct
18:53 Effective Onsite Monitoring Strategy
36:58 Onsite Monitors Roles and Responsibilities
46:40 Tools & Techniques for Effective Onsite Monitoring
48:42 Centralized Monitoring
51:52 Key Aspects of Centralized Monitoring
54:47 SDV Focus in Data Acquisition and Submission
1:00:37 Onsite and Centralized Monitoring Integration
1:14:09 Risk-Based Quality Management System
1:15:42 KPIs/KRIs/QTLs for Centralized Monitoring
1:19:25 Leveraging Technology and Data Analytics for Risk-Based Monitoring
1:21:32 Creating Holistic Monitoring Strategy
1:30:10 Conclusions
1:32:00 Q&A
About:
mindsON Centralized Monitoring (CM) is an in-depth workshop series that focuses on the practical aspects of clinical trial monitoring and daily execution. Each episode offers valuable insights, engaging discussions, and hands-on problem-solving exercises to help you overcome the challenges and complexities of monitoring in clinical trials.
Learn more: cyntegrity.com/webinars/
5 авг 2024
