Safety Database Management
Compliance
Validated Regulatory Engine
The database infrastructure is fully validated and continually updated in strict alignment with 21 CFR Part 11, EU Annex 11, and ICH E2B(R3) standards.
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Regulated Storage, Backup, and Access
Data is housed in highly secure, audit-ready cloud environments featuring automated multi-region backups and granular, role-based access logs that strictly comply with international data retention mandates.
Automation & Intelligence
Automated Quality Check
Intelligent validation engines evaluate data during entry, immediately triggering automated alerts for missing information, inconsistencies, or potential protocol deviations.
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Auto-MedDRA Coding & Labeling
Machine learning integrations accelerate data handling by instantly predicting and applying standardized MedDRA coding and expectedness labeling based on historical reference data.
Agile Commercial Model & Analytics
Flexible Per-Case Subscription
We break away from rigid, multi-year software licensing bottlenecks by offering a scalable, pay-as-you-go subscription model tailored strictly to your actual case volume.
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Real-Time Dashboard Intelligence Executive-level dashboards provide instant visibility into processing metrics, compliance timelines, and aggregate safety data, allowing for data-driven risk management at a glance