TRIAL MANAGEMENT
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.
TRIAL MANAGEMENT
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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Featured Whitepaper
ICH E6 (R2)
Summary
Paper
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.
Featured Webinar
ICH E6 (R2)
Webinar
Series
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.
We're Kind of a Big Deal.
6,000
Platform Users
1,000
Studies De-Risked
100,000
Issues Detected