STANDARDIZE, AGGREGATE, AND VISUALIZE
CLINICAL DATA FOR RISK-BASED MONITORING

RISK BASED MONITORING

In 2013, the FDA finalized their guidance on clinical trial oversight, calling for more remote and targeted risk-based monitoring (RBM), opening the door to more data driven approaches to oversee and manage clinical trial conduct. Underpinning the successful implementation of any RBM approach – whether it be by a sponsor or a CRO – is the access to data in a timely and trusted fashion.

eClinical Solutions’ elluminate®, was built specifically to address this need and provide a platform to allow organizations to standardize, aggregate, and visualize their clinical data for Risk-Based Monitoring, Remote Trial Management, Central Monitoring and Safety Signal Detection. Our approach is designed to enable Sponsors and CROs to conduct studies using RBM and remote site management and/or to use the tools to perform study oversight.

elluminate® was developed by and is supported by experienced, professional teams with expertise in Risk-Based Monitoring, data analytics, and a deep understanding of data visualizations and reporting best practices.

elluminate® provides the foundation for a successful RBM strategy and implementation. It enables all data sources to be seamlessly integrated into one central repository. Through our analytics module, we provide a standard Risk Indicator Library on site and study team performance as well as customized reports for high-risk data elements.

Contact us here for more details or to get a list of our existing standardized reports and visualizations.

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