Data-Driven Risk-Based Monitoring

Data Driven Monitoring leverages clinical operations data to guide monitoring activities

Data-Driven Risk-Based Monitoring

Data Driven Monitoring leverages clinical operations data to guide monitoring activities

Data Driven Monitoring moves away from the traditional approach of frequent and pre-scheduled on-site visits and 100 percent source data verification (SDV) toward a combination of activities, including centralized data analytics and monitoring.

Data Driven Monitoring leverages clinical operations data to guide the monitoring activities that are carried out with any given site, as an alternative to regular, scheduled monitoring visits. The type and number of monitoring activities, either on-site, off-site or central, as well as the tasks to be performed will not be defined a priori but adapted and conducted according to the results of the continuous quality and risk site management and monitoring assessment through Genius WIZARD™ Data Unification & Advanced Analytics.

By using our DDMM digital solution, we have the ability to bridge real-time information gaps between centralized analysis and in-the-field monitoring teams, reducing risk, ensuring documentation, and increasing quality.

Our Data-Driven Monitoring and Management solution uses a unique, algorithmic-based approach to clinical monitoring to determine risk and monitor workload, enabling flexible and scalable decision-making.

All study documents are managed through the Genius eTMF/eISF™, a single, secure Type II certified cloud application for sharing any study document, in a standardized and fully reportable system. Sponsor will get complete document visibility with real-time dashboards and actionable reports. This platform eliminates the need to exchange, review and collaborate on site documents, via email or fax, ensuring therefore high level of document security and confidentiality.

Using a data-driven, risk-based approach to monitoring showed significant benefits during past studies:

%

reduction of delay from the date of patient's first visit to data entry into eCRF (from 35 days down to 10 days)

reduction of SDV time by the field monitor

faster in reviewing and querying clinical data

%

days for site monitoring visits

fewer not enrolling sites

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