Are you searching for a way to meet industry peers and collaborate on complex clinical trial topics?
Hoping to exchange ideas with experts on managing trial risks? Working to dig deeper on performance management with your team? This Metrics Champion Consortium vSummit is made for you.
Through this extensive summit, you and your team will have the opportunity to delve into the ways metrics — and the careful and critical analysis of those metrics — can help you navigate your clinical trials with thoughtful effort and unprecedented success.
To prepare for this engaging summit, you will have the opportunity to view prerecorded video sessions during the 10 days before the three-day live event. Participants can join virtual community discussions and working groups, along with the virtual Risk-Based Quality Management Critical Thinking Workshop: What Can Go Wrong?
Industry experts will share how to manage risk in a high-octane environment, assess risk, gain insights from centralized monitoring, maintain data quality, and manage vendors and partnerships.
Don’t miss out on this chance to connect with your peers and engage around topics that will change your clinical trial practice for the better.
Choose from two tracks — Quality-by-Design and Risk-Based Quality Management, and Vendor Oversight — and join the discussion:
- Quality-by-Design (QbD) and Risk-Based Quality Management (RBQM) Track
- RBQM Implementation Challenges: Translating Key Risk Indicators (KRI) Descriptions into Actual Measurements
- Outsourcing Your RBQM Program: Setting Up for Success
- RBQM in Decentralized Trials
- RBQM Implementation Challenges: Documenting Your RBQM Process and Decisions
- Risk-Based Site Monitoring Models
- Implementing RBQM at Small Sponsors
- The Central Monitor Says a Risk Threshold has been Breached … Now What?
- What KRIs are Organizations Using? Is There an Emerging Core Set that You Should Start With?
- Vendor Oversight Track
- Determining the Right Metrics to Monitor Sponsor-CRO Collaborations
- Outsourcing Your RBQM Program: Vendor Oversight
- Using Metrics to Identify Issues and Drive Improvement Activities
- How to Use Metrics to Gain Insights About Site Activation and Patient Enrollment
- Decentralized Trials: How Do You Oversee and Manage New Vendors
Keynote Address:
ICH E6(R3) Guideline for Good Clinical Practice Update
M. Khair ElZarrad
ICH E6(R3) Rapporteur, FDA
Acting Director, Office of Medical Policy
CDER, FDA
Keynote Address:
ICH E6(R3) Guideline for Good Clinical Practice Update
M. Khair ElZarrad
E6(R3) Rapporteur, FDA
Deputy Director
Office of Medical Policy
CDER, FDA
Who Will Benefit:
- Clinical Operations, Management, and Research and Development staff
- Clinical Outsourcing and Vendor Management staff
- Clinical and Project Operations staff
- Performance Analytics, Management, and Reporting staff
- Metrics Reporting and Visualization staff
- Quality Management and Clinical Quality Management staff
- Clinical and Regulatory Compliance staff
- Site and Study Monitoring and Management staff
- Clinical Risk Assessment staff
- Centralized and Risk-Based Monitoring staff
- Good Clinical Practices staff
- Clinical Process Optimization staff
- Vendor Oversight staff
- CRO companies
- Risk-based monitoring companies
- Central, Imaging, and ECG labs
- eCOA and ePRO companies
- eTMF companies
- CTMS companies
- EDC companies
- Data Aggregation and Visualization companies