Changing FDA expectations, risk-based monitoring, and ever-growing demands for cost efficiency are fueling dramatic developments in the world of clinical research. Clinical trial monitors are on the front line of these changes, and must adapt to the world of centralized risk-based monitoring, quality systems-based approaches, and sophisticated technologies designed to improve outcomes. CHI will be addressing these issues at its sixth annual Mastering Clinical Trial Monitoring conference. We are pleased to announce this Call for Abstracts, seeking thought leaders to share their insights into addressing these challenges and exploiting these opportunities via presentations, case studies, and hands-on activities.
We invite abstracts on topics that include, but are not limited to:
- Risk-Based Monitoring (RBM) Implementations: Keys to Success, Cost-Effectiveness, and Desired Outcomes
- TransCelerate Pilot Study Update and New Recommendations: Implementation Challenges, Opportunities, and Lessons Learned
- Using a Quality-by-Design (QbD) Foundation to Support Risk-Based Monitoring
- Quality Risk Management (QRM): Developing Metrics and Key Risk Indicators (KRIs) to Proactively Identify and Mitigate Risk
- Key Risk Indicators (KRIs): How Should They be Used? What are Their Value? Are They Reliable? How are They Assessed?
- FDA Inspection Trends: Expectations, Preparation, Documentation, Delegation, and Follow-Up
- Trial Master File Setup and Maintenance: Avoiding TMF-Related Inspection Findings
- Site Training that Ensures Compliance, Commitment, and Success
- Site Relationship Management Techniques: From Site Selection, Management, Support, and Escalation Techniques
- Strategies, Processes, and Technologies to Support Adaptive Risk Management
- Using Analytics and Visualization Tools to Identify and Evaluate Risk and Support Decision-Making
- How RBM Impacts the Monitor: Site Management, Monitoring Plans, and Data Management
- Monitoring International Clinical Trials: Addressing Challenges Associated with Culture, Language, and Regulatory Bodies
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. To submit a proposal for consideration, please click here
The deadline for priority consideration is December 17, 2014.
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 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.
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