What should clinical research industry stakeholders keep in mind when implementing and managing risk-based quality management programs?
How is the FDA using data to quantify risk to determine where to conduct site inspections?
The Clinical Trial Risk and Performance Management Summit and Dr. Jean Mulinde, Senior Advisor, Division of Clinical Compliance Evaluation, CDER, FDA have the answers.
Come to Princeton Nov. 14 and 15 for the first-ever Metrics Champion Consortium Summit. This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Executive Director Linda Sullivan. The keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, clinical trials guru, founder of CenterWatch and an MCC partner. Plan on attending this must-see presentation: Next Gen Benchmarking in Biopharma by Linda Martin, President and Founder, The KMR Group.
The roster of experts will guide attendees through the issues that are top of mind in clinical trials metrics today:
- How is ICH-E6(R2) changing what needs to be measured? What are global regulators looking for?
- How do metrics influence behavior? Is it rewarding firefighting or preventing problems? Does staff have the critical thinking skills needed to root out what needs to be changed?
- Centralized monitoring. How is industry approaching key risk indicators and quality tolerance limits?
- Getting to the root of the problem. Pros and cons of traditional analytic approaches: Is there a better way?
- Predictive analytics. The next-level key to success. But how to get there?
The Clinical Trial Risk and Performance Management Summit is interactive. Attendees roll up their sleeves with speakers and fellow attendees as they tackle case studies that will bring clarity to the metrics process—and provide needed answers.
Who Will Benefit:
This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:
- Clinical Operations/Management/ Research/Development
- Clinical Outsourcing/Vendor Management/Third-Party Management
- Clinical/Project Operations
- Performance Analytics/Management/Reporting
- Metric Reporting/Visualization
- Quality Management/Clinical Quality Management
- Compliance/Clinical Compliance/ Regulatory Compliance
- Monitoring/Site Management/Study Management
- Clinical Risk Assessment
- Centralized Monitoring/Risk-based Monitoring
- Good Clinical Practices
- Clinical Process Optimization
- Vendor Oversight
Clinical Trial Risk and Performance Management Summit
Presented by Metrics Champion Consortium a Division of CenterWatch
Nov. 14-15, 2018 – Princeton, NJ
Early Bird Pricing: $1,597 (available until Oct. 17, 2018)
Regular Pricing: $1,797 (after Oct. 17, 2018)
Significant team discounts are available.
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
Leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. Founded in 2006, MCC is the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. MCC provides the collaborative environment for biopharmaceutical and device sponsors, service providers and sites to improve clinical-trial development through use of MCC standardized performance metrics.