The planning and execution of clinical trials is on a continuous journey to leverage the benefits of risk-based approaches and Quality by Design. Regulatory guidance such as ICH E6 (R2) is advocating early, proactive risk identification, proportionate response and efficiency in the way that those risks are managed. To date, we see this already impacting clinical trials through the implementation of risk-based approaches to Monitoring.
Legacy “One size fits all” practices such as 100% Source Data Verification are being replaced with risk-based, targeted and more sensitive techniques to focus on the “Issues that matter”. The value of risk-based approaches doesn’t stop with Trial Monitoring, it transcends functional boundaries within organisations and is equally applicable in the domain of Clinical Data Management.
Join our webinar on March 30, 2021 at 10:00 am EDT to learn about the concept of risk-based approaches to Clinical Data Management, the benefits of adopting risk-based practices and:
- The pressures and changing landscape of Clinical Data Management
- Opportunities for ROI by adopting a risk-based approach
- Technical capabilities that can support Data Management
- Early experience and barriers to adoption
- Moving forward with risk-based Data Management
Your Hosts
- Rich Davies, VP, Solutions Expert, CluePoints
- Tanya Du Plessis, VP, Data Strategies, Bioforum
