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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Our Customer Support team is readily available to address your issues regarding questions about our software or to assist with technical difficulties. If you need to contact us, simply submit your message and a representative will reply to your inquiry as soon as possible.
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