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Trial Management Products

Trial Management Products Powered by Central Statistical Monitoring

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risk assessment and mitigation

Risk Assessment

Industry guidance, namely the FDA’s Integrated Addendum to ICH E6 (R1), calls for Sponsors to adopt a quality system that utilizes a “Risk-Based Approach” regarding critical processes and data identification. Not just for the monitoring part, but for risk identification, evaluation, control, communication review and reporting.

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Signal & Action Tracker

The Signal and Action tracker unifies all sources of potential issues into a workflow where a structured review and evaluation can take place. Cross-functional input can be documented with actions being assigned as required to implement corrective procedures. All Signal & Action management is documented to provide a single source of truth regarding clinical trial issues and their management to resolution.

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Signal and Action Tracker Screenshot

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Featured Whitepaper

ICH E6 (R2)

Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides insights on how companies are responding to ICH E6 (R2) and information on the key themes on adoption.

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Featured Webinar

ICH E6 (R2)

This recorded webinar covers all of the frequently asked Questions about ICH E6 (R2), Risk-Based Study Execution (RBx) and what’s required from a people, process & technology standpoint.

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Studies De-Risked


Issues Detected