Why Attend the CluePoints La Jolla Roadshow?
If like many other sponsors and CROs, especially those with smaller, early-phase studies, your company is unsure how to implement ICH E6 R2 guidelines in terms of a prioritized, risk-based approach to both quality management and/or monitoring this event will demystify the guidance, leaving you with a clear roadmap on how to achieve the “gold standard” approach. We will explore the following:
- The key updates within ICH E6 R2 and how to drive compliance for your organization
- Why RBx is the future for all clinical studies & the benefits that can be derived from this holistic approach
- How to ensure that the starting point for your study is a fit for purpose RBx approach based on the size and complexity of your study from Phase I to Phase IV
- The value in aggregating study data to make better decisions (e.g. Quality Tolerance Limits) based on industry metrics
- Best practice for study planning and execution, including pre-study risk assessment, risk controls and documented issue mitigation
- Case studies that illustrate the benefits of using an automated statistically-driven approach
- Our vision of RBx for the next 2 years.