Overview

Glooko's Clinical Research platform is a comprehensive, FDA 21 CFR Part 11‑compliant solution designed specifically for diabetes clinical trials and real‑world studies. It enables life science organizations to harness granular, near-real-time patient data from over 200 diabetes devices across 8,000+ global clinics. The system streamlines every phase of clinical research—from protocol design and site‑selection to recruitment, monitoring, and data export—while ensuring adherence, data privacy, and multi-device integration

Features and Capabilities

• Regulatory Compliance: Fully compliant with FDA 21 CFR Part 11, HIPAA, GDPR, and ISO 13485
• Extensive Real‑World Data: Aggregates 100 billion+ data points spanning glucose, insulin, activity, food, BP, weight, and demographics
• Vast Device Support: Integrates with 200+ diabetes and health monitoring devices (BGMs, CGMs, insulin pens, pumps, smart scales, fitness trackers)
• Protocol Design Aid: Utilizes real-world data from 8,000+ clinics to optimize device selection and trial feasibility
• Site Selection & Recruitment: Leverages data insights to identify optimal trial locations and participants
• Remote Data Capture: Enables continual, near real-time data collection during hybrid or decentralized trials
• Patient Monitoring Tools: Dashboards for sponsors and sites to track adherence, device usage, and performance metrics
• Flexible Data Export: Supports exporting in multiple formats for statistical analysis and EDC system integration
• Data Tokenization: Ensures rich, longitudinal patient data while maintaining privacy
• Participant App & Uploader: Syncs data from BGMs, pumps, pens, and CGMs via mobile app or desktop uploader; supports blinded study modes
• Support for Healthcare Professionals: Offers uploaders, SSO, population health tracking, risk‑identification tools, and professional dashboards