Abstract
TransCelerate BioPharma Inc developed a methodology based on the notion that shifting monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring will increase efficiencies and enhance patient safety and data integrity while maintaining adherence to good clinical practice regulations. This philosophical shift in monitoring processes employs the addition of centralized and off-site mechanisms to monitor important trial parameters holistically, and it uses adaptive on-site monitoring to further support site processes, subject safety, and data quality. The main tenet is to use available data to monitor, assess, and mitigate the overall risk associated with clinical trials. Having the right technology is critical to collect and aggregate data, provide analytical capabilities, and track issues to demonstrate that a thorough quality management framework is in place. This paper lays out the high-level considerations when designing and building an integrated technology solution that will aid in scaling the methodology across an organization's portfolio.
Highlights
Successful implementation of risk-based monitoring (RBM) is largely dependent on 3 critical factors: people, process, and technology
TransCelerate BioPharma Inc developed a methodology based on the notion that shifting monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring will increase efficiencies and enhance patient safety and data integrity while maintaining adherence to good clinical practice regulations
The following end user criteria were identified for inclusion in a technology solution and categorized into 2 major areas:
Summary
Successful implementation of risk-based monitoring (RBM) is largely dependent on 3 critical factors: people, process, and technology. Tools were developed to support the approach and enable implementation of RBM processes within a sponsor’s organization. Such tools are targeted at both people and processes, and revisions have been and will be made as experience with the RBM methodology increases. These tools speak to people aspects, such as change management, training, and stakeholder communications. Simple data capture and presentation were initially thought to be sufficient; namely, identification of the risk indicators, capture and comparison of the data to thresholds, and presentation were considered the basics of any system (Figure 1)
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