Mastering Clinical Trial Monitoring
Boston, USA (June, 04-05, 2012)
The Third Annual Mastering Clinical Trial Monitoring conference will focus exclusively on the changing role and expanding expectations of the experienced clinical trial monitor. Building on the overwhelming success of previous events, thought leaders will share their experiences related to implementing risk-based monitoring plans, enhancing the monitor's job performance with hands-on techniques and tips, and improving site performance and data integrity. Themes throughout the conference will be building risk-based monitoring plans, monitoring global clinical studies, incorporating the latest regulatory requirements and expectations into your monitoring activities, and meeting the challenges of monitoring in an electronic environment. Attendees can expect sessions that feature case studies, hands-on activities, take-away tools, and interactivity.
Conference Program:
Risk-Based Monitoring Case Studies
- Risk-Based Monitoring: Abbott Vascular's Enhanced Monitoring Initiative
- A Risk-Based Approach to Monitoring: A Sponsor's Perspective
- Lessons Learned through a Challenging Site FDA Audit: A Case Study
Quality System-Based Approaches to Clinical Trial Monitoring
- FDA Draft Guidance on Risk-Based Monitoring of Clinical Trials
- Clinical Site Issue Escalation: A Vital Process in Clinical Quality Management
- Transitioning from Auditing to a Quality Improvement System
Monitoring Techniques, Tips, Tricks, and Apps
- Selecting the Right Sites the First Time: How to Use the Pre-Study Visit to Increase Trial ROI
- Monitoring 2.0: Root Cause Analysis and CAPA Planning at Investigative Sites
- Tools, Tricks, Tips, and Apps: Making Monitoring Easier
Site Relationships Management and Performance Improvement
- Site Relationship Management: Achieving Compliance and Commitment
- From Monitoring to Site Management: The Evolving Role of the CRA
- Partnering and Visibility though Effective Communication
- Site Management through Analytics, Relationships, and Teamwork: Optimizing Relationships for Performance
- Applying a Quality Systems Approach to Clinical Research
Monitoring in Unique Environments
- Meeting the Unique Challenges of Medical Device Study Monitoring
- Monitoring Investigator-Initiated Trials within a Pediatric Research Institute
- Monitoring the Academic Medical Center: Exploring the Challenges and Opportunities of AMCs
- Monitoring Investigator-Initiated INDs/IDEs in an Academic Setting: Challenges and Lessons Learned
