Automation
Pharmaceutical Research Data Management
Lyon Pharmaceuticals SA
A GxP-compliant data management solution for clinical trial data collection, laboratory results tracking, and regulatory submission preparation.
The Challenge
The pharmaceutical company needed a validated system for managing clinical trial data, ensuring 21 CFR Part 11 and EU Annex 11 compliance, while streamlining regulatory submission preparation.
Our Solution
We implemented a validated Power Platform solution with electronic data capture forms, laboratory information management, audit trail logging, electronic signatures, and automated report generation for EMA and FDA submissions.
Results & Impact
Data entry errors reduced by 95%, regulatory submission preparation time cut by 60%, and achieved full GxP validation with zero critical findings in audits.
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