Greenlight Guru Clinical
The only EDC designed for MedTech.
Overview
Greenlight Guru Clinical (formerly SMART-TRIAL) is an EDC platform built specifically for the needs of medical device and diagnostics companies. It helps manage data for pre-market and post-market clinical studies, ensuring compliance with relevant regulations like ISO 14155 and the EU MDR. While primarily an EDC, it includes features for managing study conduct that overlap with CTMS.
✨ Key Features
- Electronic Data Capture (EDC)
- ePRO & eConsent
- Randomization
- Medical Device-Specific Templates
- Compliance with ISO 14155 & EU MDR/IVDR
- Post-Market Clinical Follow-up (PMCF) support
🎯 Key Differentiators
- Exclusive focus on the medical device and diagnostics industry
- Built-in compliance with MedTech-specific regulations like ISO 14155
- Expert support and templates tailored to medical device trials
Unique Value: Provides medical device companies with a purpose-built, compliant, and user-friendly platform to manage their clinical data and accelerate market access.
🎯 Use Cases (3)
✅ Best For
- MedTech companies seeking regulatory approval in the US and EU.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Large pharmaceutical trials requiring comprehensive operational and financial CTMS features.
🏆 Alternatives
Unlike generic EDC systems, it is pre-configured for medical device standards and workflows, reducing the burden of customization and compliance validation for MedTech sponsors.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Dedicated Support (All tier)
🔒 Compliance & Security
💰 Pricing
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