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Protocol Deviations

Streamlining Management for Better Compliance and Insights

Managing protocol deviations is critical to ensuring trial integrity and participant safety. elluminate® Protocol Deviations centralizes all deviation data, streamlining ingestion, standardization, and trend identification across diverse sources, including CROs, CRAs, and CTMS systems. By eliminating manual, siloed processes, sponsors can achieve real-time insights, enhanced oversight, and regulatory compliance.

Key Benefits of elluminate® Protocol Deviations

elluminate® Protocol Deviations delivers efficiency, quality, and compliance by automating data ingestion, centralizing deviation management, and providing actionable insights. Sponsors can make smarter decisions and ensure trial success with real-time analytics and standardized workflows.

Greater Efficiency

Automated ingestion and mapping minimize manual errors, while consolidating protocol deviation data from all sources into one platform streamlines management.

Enhanced Quality

Centralized data ensures consistent reporting and reduces discrepancies, with standardized Protocol Deviation Assessment Plans (PDAPs) enabling uniform data review across studies.

Ensured Compliance

Real-time analytics support timely issue resolution and regulatory adherence, while standardized data and transparent workflows demonstrate sponsor oversight.

Smarter Decisions

Interactive dashboards provide a comprehensive view of deviation metrics, including counts and trends, empowering data-driven decisions to mitigate future deviations.

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Feature Highlights

elluminate® Protocol Deviations provides a comprehensive suite of tools, including standardized frameworks, customizable plans, and interactive dashboards, to ensure consistent, efficient, and insightful protocol deviation management across all studies.

Global PDAP: Establishes a standardized protocol deviation framework across all studies.

Study-Specific PDAP: Customizes deviation management for individual trials, inheriting global standards while allowing unique guidelines.

Interactive Dashboards: Deliver actionable insights into protocol deviations, ensuring efficient management and enhanced oversight.

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Empowering Life Sciences Organizations for Trial Success

elluminate® Protocol Deviations equips sponsors and CRO organizations with the tools to address today’s data challenges. From ensuring data consistency to leveraging real-time insights, our platform empowers sponsors to deliver high-quality trials while meeting compliance standards efficiently.