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% SDV 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 organizations and is equally applicable in the domain of clinical data management.
Watch this on-demand webinar to learn about the concept of risk-based approaches to Clinical Data Management and the benefits of adopting risk-based practices.
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