Adopting Site Quality Management to Optimize Risk-Based Monitoring




As it is now well documented, clinical R&D organizations have been actively embarking on a paradigm shift in their approach to ensuring quality in the conduct of clinical trials. In particular, a more targeted, risk-based approach to site monitoring and data cleaning is being actively pursued by organizations both large and small. The primary goals of this new paradigm include significant improvements in resource efficiency associated with clinical R&D, increased quality in trial conduct and corresponding data, and the maintenance or even reduction of clinical trial timelines.

While the interest in this paradigm has increased steadily in recent years, progress had been significantly impeded by a variety of factors. However, now that electronic data capture (EDC) technology is near ubiquitous and the FDA has delivered guidance in favor of centralized monitoring, sponsors are now more interested than ever in trying to implement a risk-based monitoring strategy.

This white paper will help you understand the challenges faced when implementing risk-based monitoring and how developing a site quality management program, especially one leveraging real-time site quality analytics, can simplify the adoption and increase your chances for success.

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