Modernizing Clinical Trial Operations: EU CTMS Visualization & AI Platform

Kyowa Kirin, a global giant in complex pharmaceuticals, operates highly complicated clinical trial portfolios across the European Union. Managing trials is a high-stakes balance of keeping patients safe, monitoring regulatory compliance (GDPR and EMA guidelines), and tracking multimillion-dollar operational costs. Clinicians and researchers struggled because their primary operational records were dispersed in Microsoft Dataverse silos. The business desperately needed a wireframe-perfect, consolidated reporting tier that served as a proactive risk evaluation engine, rather than static post-hoc sheets.

As BI Team Lead, I drove end-to-end visualization architecture on Microsoft Fabric. We arranged a Medallion architecture inside Fabric Lakehouse: Bronze (raw ingestion from Dataverse), Silver (validated structures), and Gold (optimized Star Warehouses). I designed a rigorous clinical suite consisting of four distinct analytics layers: Study Progress tracking recruitment rates, Site Monitoring tracking Source Data Verification (SDV) backlogs, RBQM analyzing protocol deviations, and Financial pipelines tracking accruals currency-converted to EUR. We integrated Copilot Studio for quick natural-language clinical queries and connected Data Activator to fire automated alerts upon threshold breaches.