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Clinical Trial Risk and Performance Management Summit
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95% of those polled in 2018 found the summit to be excellent!
Is your organization inundated with information and unable to focus on what matters?
Does your staff struggle with analytical, critical thinking skills needed to manage risk and uncover opportunities to drive real change?
Come to the Clinical Trial Risk and Performance Management Summit and discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure; establishing your data requirements; aggregating reliable data; designing easy to understand metric reports; and using metrics to identify areas of concern and conduct root cause analysis.
Check out this sampling of what you’ll explore over the course of an information-packed day-and-a-half:
- ICH-E6(R2): This international guideline continues to challenge contract research organizations, sponsors and others. How do regulators use data to determine where to conduct inspections? What challenges has risk-based quality management presented to others? How should you address such challenges? Get ready for answers — from FDA, MHRA and EMA officials as well as industry top thinkers.
- Squeezing Max Value Out of Data: Do your metrics answer the high-priority questions, reward the right behaviors, give you reliable time/quality readings? Speakers and panelists are ready with answers.
- Data Quality: Designing data reports end-users can read and understand… aggregating in-house and CRO/vendor data… data governance and stewardship… and much more.
- Predictive Analytics: Predictive analytics can help you with site selection, quality indicators and more. Discover savvy new ways to apply and test findings.
- Critical Thinking Skills: Staff can be the weakest link. Discover creative new ways to move away from a ‘check the box’ mentality.
Join us at the Clinical Trial Risk and Performance Management Summit to explore how you can address these challenges.
Network and problem solve with your peers by choosing one of two tracks, vendor oversight and risk-based quality management.
Summit by the Numbers
1 plenary session
1 keynote speaker
2 concurrent breakout tracks
1 networking reception
1 member dinner
9 networking opportunities
15+ speakers
PLUS MCC Demonstrations
Learning Objectives
- Consider the impact of ICH E6(R2) on your data collection and monitoring.
- Establish metrics to answer your organization’s key risk and performance questions.
- Build strategies and address challenges for risk and performance management program implementations.
- Take effective action to improve results using data analytics.
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Testimonials
“Great forum of people with similar goals and mindsets.”
— Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences
“Excellent conference. Would definitely come back and recommend to others.”
“Best conference for me. Extremely interactive and I learned a lot. Great participation from Audience.”
“Please continue to create such a great environment for collaboration!”
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