Risk Based Monitoring

The future of clinical trial monitoring is here with a significant trend toward adopting a risk-based approach to enable more efficient trial delivery without reducing subject safety or data integrity.  The risk-based approach, defined by initial and clear risk assessment which becomes a part of active study management, is methodology supported by both the EMA and the FDA to improve the overall speed and quality of study delivery and enable faster response to potential safety signals. 

Once a company has decided to move forward with risk-based monitoring (RBM), one of the early steps clients take is to evaluate which tools best fit their needs. Judging by all the press that RBM technologies are receiving you would think that the tools/systems that exist currently satisfy the needs of the industry. However, each tool has its own strengths and weaknesses.

In order to correctly choose a tool, a company needs to identify which capabilities are required from the
RBM solution. At a high level, RBM requires several core capabilities:

  • Study Design
  • Data Integration/Aggregation
  • Reporting/Analytics
  • Workflows/Resolution
Study Design

The first step of implementing RBM for a study is to perform a risk assessment and then design the protocol, monitoring approach, and stats approach. Several of the RBM tools that reside as part of a bigger eClinical suite offer this capability, but some of the stand-alone tools will require augmentation by additional tools/processes.

Data Integration/Aggregation

Once you have defined your approach, you will need to have access to the relevant data. Unfortunately, many of the emerging platforms today are limited by data source requirements or integration limitations. EDC-based RBM tools require use of a specific EDC database and typically cannot aggregate data from outside EDC database sources, potentially impacting use of historical information despite transitioning to the product. CRO-based RBM tools generally require outsourcing all studies to that specific CRO in order to utilize the full power of your study data.


Analytics are the capability that receive the most interest from many stakeholders and are where many of the vendors have placed the most investment. This has resulted in reporting/analytics tools that are impressive in their functionality and utility.


Once data has been aggregated and reported against, it is up to the clinical team to act upon this information. Unfortunately, this capability is the one that is most likely to be inadequately addressed by RBM tools. The ability to manage/track issues, manage documentation, or initiate workflow lacks in the risk-based monitoring tools currently available.

So what is a company to do when none of the leading RBM vendors provide tools that have gaps in key areas? The answer is that life sciences companies need to realize that their RBM solution is not going to be just one tool and that they will have to implement several processes/systems to get the outcomes they desire. In order to understand what their holistic RBM solution needs to contain, we suggest that clients perform a process- and capability-driven assessment of their needs and then let that drive tool selection.  Paragon has a best-practice RBM capability map that can assist companies with this process of identifying how they fulfill the capabilities needed to execute risk-based monitoring. Click here to learn more about Paragon’s Risk-Based Monitoring Services and Capabilities.

If you’re assessing, implementing, or would like to optimize the risk-based monitoring tools and capabilities for your organization, request a complimentary consultation with one of Paragon’s RBM subject matter experts to discuss options that fit your organization's unique challenges and goals

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