Barnett International/CHI’s Fifth Annual
Mastering Clinical Trial Monitoring
Optimizing Site Performance and Improving Efficiency with Risk-Based Monitoring
June 2-3, 2014, Hilton Boston Back Bay, Boston, MA
At this time of change and growth for clinical trial monitors, Barnett International/CHI is pleased to announce a Call for Speakers for our fifth annual Mastering Clinical Trial Monitoring conference. Focusing exclusively on the changing landscape and evolving role of clinical trial monitors, this event will bring together thought leaders to share their experiences and insights related to the industry’s most topical issues such as the FDA’s Final Guidance on Risk-Based Monitoring, the impact of TransCelerate’s efforts in the industry, monitoring international clinical trials, and quality systems-based approaches to monitoring. We seek thought leaders to provide insights, case studies, hands-on activities, and take-away tools for monitors.
We invite presentations on topics such as:
- How Does the FDA’s Final Guidance on Risk-Based Monitoring Affect Monitoring Strategy?
- Differences Between the FDA’s Draft and Final Guidances on Risk-Based Monitoring
- Utilizing Risk-Based Monitoring to Enhance Subject Safety and Data Integrity
- Monitoring High Risk Sites: Increased On-Site Monitoring vs. Remote Monitoring
- FDA’s Final Guidance: Alternative Remote Monitoring Techniques
- Creating Quality Systems-Based Approaches to Monitoring
- Techniques for Optimizing Clinical Trial Site Performance
- The Physician Payment Sunshine Act: Practical Tips for Compliance
- Updates and Insights into TransCelerate's Efforts to Develop a Standard Framework and Approach to Risk-Based Monitoring
- Managing Outsourced Clinical Trials
- Monitoring International Clinical Trials, Addressing Challenges Associated with Culture, Language, Source Data Verification (SDV), and Regulatory Bodies and Their Expectations
- Monitoring in Unique Environments: Academic Medical Centers, Medical Devices, and Clinical Resource Organizations
- Managing FDA Site Inspections and Their Consequences
- Site Relationship Management Techniques: From Site Selection, Management, Support, and Escalation Techniques
- Best Practices for Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA)
- FDA Inspection Trends: Expectations, Preparation, Documentation, Delegation, and Follow-Up
- Monitoring in the Electronic Environment: Electronic Data Capture (EDC), Electronic Medical Records (EMRs), and Electronic Storage Systems
- Tools and Apps for Monitors: Making Monitoring More Effective and Efficient
Industry professionals with best practice case studies and other thought leaders are encouraged to submit a session title, summary of a proposed presentation, and brief biography for consideration.
The deadline for priority consideration is November 15, 2013.
All proposals are subject to review by the program Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference is given to abstracts from those within pharmaceutical and biotech companies, regulators, and those from academic centers. Additionally, as per Barnett/CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
To submit a proposal for consideration, please click here.
For more information, please contact:
a division of Cambridge Healthtech Institute
For exhibit and sponsorship information, please contact:
Manager, Business Development
Cambridge Healthtech Institute