Clinical Trials 360 — Trial Operations & Safety Intelligence on Sigma
Clinical Trials 360 — Trial Operations & Safety Intelligence on Sigma
Built for Trial Operations Leads, Site Managers, and Clinical Data Managers. Provides real-time visibility into four headline KPIs — Total Enrolled (456), Enrollment Target (533,344), Screen Failure Rate (18%), and Active Sites (812) — with live drill-down into:
Sigma AI Agent — Natural Language Analytics Available across both dashboards. Clinical and PV users query in plain English — governed, row-level-secured answers delivered instantly from live Snowflake data. No SQL. No IT dependency. Example queries:
Safety Signal & Pharmacovigilance Dashboard Built for Pharmacovigilance Scientists, Medical Monitors, and Regulatory Affairs teams. Tracks four safety KPIs — Total Adverse Events (1,143), Serious Adverse Events (200), SAE Rate per 100 Subjects (17.50), and Open Unresolved AEs (388) — with:
Authorised users — PV Scientists, Site Coordinators, Clinical Data Managers — update case notes, flag records for review, resolve adverse event statuses, add site annotations, and trigger workflow actions directly within Sigma. All changes write back to Snowflake via governed API — audit-ready, traceable, and GxP-compliant. The regulatory record stays clean without leaving the analytics environment.
Four personas — Clinical Data Manager, Pharmacovigilance Scientist, Commercial Analyst, Life Science Admin — each see only the data their role authorises. Enforced by Snowflake RBAC, not app-layer filters. Trial Ops users see enrollment gaps. PV Scientists see live SAE signals. Commercial Analysts see aggregate data with patient-level masking.
This solution is built natively on Sigma not retrofitted. Sigma is the only BI platform that eliminates the extract layer entirely, querying Snowflake live at billion-row scale. For life sciences, that means PV Scientists get Grade 4 SAE signals the moment they are recorded not at the end of the week. The GxP ready writeback layer means every action taken in Sigma is traceable, governed, and audit ready. And the AI Agent means a Pharmacovigilance Scientist can query 1,143 adverse event records in plain English
without SQL, without a data team, and without waiting.