Register for the 2018 Clinical Performance Metrics & Analytics Summit, December 6th and 7th, 2018. Todd Johnson, Principal Consultant at Halloran Consulting Group, is a panelist. Use code HALLVIP for 15% off of your registration.
See the full agenda here.
UTILIZE METRICS TO EFFECTIVELY MONITOR RISK AND COMPLIANCE
Hosted by Tim Koch, Global Head of Clinical Analytics
Novartis Pharmaceuticals Corporation
Last year, the FDA began to require sponsors to proactively list risks and monitor accordingly. With the addendum ICH E6 R2 putting a larger emphasis on the responsibilities of CROs and sites to create a system for prioritizing risk-based approaches to how they monitor their clinical trials, sponsors and investigators are overlooking some key issues.
This panel will explore how all parties can stay on top of these overlooked issues and how metrics can be used to ensure that processes are not overlooked. Attendees will learn:
• How organizations are implementing a risk-based approach to oversight.
• Which key risk indicators (KRIs), performance metrics, and data points are being reviewed and who is responsible for reviewing them
• How trial design has evolved in a risk-based approach
• Lessons learned and best practices that can be shared around remote sites and even remote patient visits