Benefits of RBM

The principles of centralized analytics used extensively in other industries have been observed to have multiple benefits, including improved quality of operations and product, with an associated lower cost. These principles can be effectively applied to pharmaceutical development and clinical trial monitoring through risk-based monitoring (RBM). 

While paper-based data collection is a practice that still occurs in clinical trials, the industry is increasingly shifting towards processes that digitize clinical data.

Digitization specifically impacts the earlier detection of data quality issues, making possible a string of actions that weren’t feasible in a paper-based paradigm, most notably, a comprehensive risk-based monitoring (RBM) approach. RBM can involve the entry and storage of digital data, which improves quality by bringing data collection and tracking in real-time, and trends and analytic capabilities to the forefront. Digitization contributes to RBM’s core goals:

1. Controlling and ensuring that clinical data quality is accurate, complete and verifiable
2. Enhancing the safety of patients in a clinical trial, ensuring the rights and well-being of human subjects are protected

Adoption of an RBM methodology can lead to increases in Quality Data, Patient Safety and Efficiency. Specifically, it can enable:

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Reduction In Efforts

Reduction in efforts expended on low-value activities; get more for what you invest

Cost Reductions

Cost reductions through more focused Centralized monitoring activities and targeted On-site monitoring

Focus

Focus on study-specific critical data and processes

Early Detection

Earlier detection of issues, with a greater focus on resolution and prevention of issue recurrence

Compliance With Protocol

Ensuring a study is compliant with the protocol, Good Clinical Practice (GCP)² and relevant regulatory requirements

Collaborative Approach

A more collaborative cross functional team approach – the coordination of monitors, data managers, statisticians, medical monitors and site staff

Through centralization and data analysis triggered by risk-based monitoring, clinical trial operations can unleash specifc improvements for stakeholders.

What are the specific and important benefits that RBM enables for investigator sites, regulators, sponsor companies and patients?

RBM reduces burdens associated with trial monitoring to sharpen the focus what matters most: the patients, the science and industry innovation.

2. US FDA, “Good Clinical Practice 101: An Introduction.”  US FDA