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Top 5 Criteria for Your RBM Software Selection

There is increasing recognition of the importance of implementing risk-based monitoring (RBM) systems to aid with the monitoring and reporting of relevant risks in clinical trials, rather than relying on traditional methods based on disparate data sources and manual collation processes. Software-based RBM systems automate predetermined monitoring tasks, provide alerts for identified risks and can provide audit trails for regulatory submissions. However, all RBM systems are not the same. Based on my experience with RBM, here are the top 5 criteria that I consider important when selecting a software-based RBM solution that will be an integral part of your overall Quality Management System (QMS).

  1. Is the vendor the right fit for you?
    This might be your first consideration of an RBM system. You might be aware of the regulatory requirements but have yet to implement a system or you might already have a system in place but want to find a system that better fits your needs. Regardless of where you are in your RBM journey, the vendor that you choose should be sensitive to and able to provide the right services/support for your specific RBM needs. Are you looking for your technology vendor to be hands off, or are you looking for your RBM vendor to be subject matter experts with experience to help you navigate business process and regulatory decisions aligned to the software implementation?

  2. Does the RBM system support the latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum?
    In particular, the new section 5.0 outlines recommendations for quality management within seven specific areas including Critical Process & Data Identification, Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Reviews and Risk Reporting. These guidelines form the basis for companies to undertake and execute clinical trials using a quality risk management approach, and having the right technology in place to support compliance with these guidelines is essential. I recently described specific considerations for each of the seven areas in this blog post.

  3. Does the RBM system integrate with other systems?
    In other words, to what extent is the RBM system open source or data agnostic? No two clinical trials are the same, and data for risk monitoring might need to be pulled from different external systems for each trial. Therefore, you'll want to evaluate whether the RBM system is flexible enough for your future needs and what limits will be placed on integration. Understand the integration cost implications of working with your vendor. Do they charge for each integration, or do they have accelerators built for commonly used systems that can be leveraged to reduce costs?

  4. What type of risk assessments and analytics are supported?
    You should evaluate the built-in risk assessment tool for its usefulness, flexibility, ability to be changed when necessary, accommodation of all the risks and reflection of the TransCelerate recommendations.

    The ideal tool also blends the human and statistical viewpoints to provide a well-rounded, robust view of risks in your study. What does this mean exactly? A number of tools will allow you to set up triggers and thresholds for alerts regarding potential risks, but do those tools also combine machine learning algorithms and pattern analyses that help identify trends that were not anticipated at the start? These predictive analytics enhance patient safety and complement your team's knowledge of the potential risks associated with a compound or device.

  5. Does the system support data visualization and workflow capabilities?
    The most efficient method to achieve trial oversight is through data visualization, which provides data in formats to easily identify trends and outliers. Systems that incorporate both standardized and customized charts, graphs and reports on demand provide actionable insights about how to best mitigate risk. Near real-time views of information are facilitated by full integration of external data sources, providing a grander overview of your trial.

For further quality control and compliance with regulatory requirements, a complete audit trail is also important. Integrated systems that track all actions within the QMS are ideal for this purpose.

Having the right technology in place to support your RBM needs and compliance with the guidelines is essential. The above suggestions can be used by companies who have an existing RBM solution in place, to identify where it could be improved to ensure that it aligns with your QMS and supports compliance, and for companies just starting their technology selection process, to ensure you select a technology that can act as your QMS while at the same time supporting RBM methodologies.

Our ClearSiteTM RBM technology was developed with these criteria in mind, to provide our customers with a comprehensive, integrated QMS and RBM solution. For more information about ClearSiteTM, please contact me at

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