Product Overview
Greenlight Guru Clinical (formerly SMART-TRIAL) is a single, compliant platform for collection and management of all clinical evidence, safety, and performance data.
Every Feature Made for MedTech: Your software is already optimized for medical device studies. That means no coding, no stressful setup, and no expensive pharma-centric features you’ll never use.
Pre-validated per FDA and ISO 14155:2020: Ensure compliance from the start with built-in ISO 14155:2020, EU MDR, and FDA requirements. In addition, you’ll get 13 ready-to-use and customizable compliance document templates.
Support for multi-indication device studies: Easily make adjustments to your study designs according to different countries’ requirements and EC approvals.
Support for dynamic visits and treatments: If your study subjects require one or many treatments with your device, you can use multiple activations for any visit event.
3-Step study builder: Set up a study in as little as 90 s
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
What integration capabilities does Greenlight Guru's EDC software offer with other systems or tools commonly used in clinical research? Greenlight Guru Clinical’s API supports two-way communication to push and pull data directly to and from your study. Our API integrates with third-party applications, supports multiple devices, and allows for fast and secure transfer of any data into the study of your choice.
What are the benefits of using role-based access control in EDC systems? Role-based access control (RBAC) ensures that study personnel can access only the data and tools necessary for their specific responsibilities. This minimizes the risk of unauthorized data access, enhances security, and supports compliance with regulations like ISO 14155:2020 and EU GDPR. By tailoring access permissions, RBAC helps maintain data integrity and fosters accountability across study teams.
How does Greenlight Guru Clinical handle multi-language support for global studies? Greenlight Guru Clinical supports multi-language studies by enabling localized eCRFs, ePROs, and other data collection tools in more than 40 languages. This ensures participant comprehension, improves data quality, and allows clinical teams to manage studies seamlessly across multiple locations. With customizable translation workflows, our system helps streamline global study operations.
Can Greenlight Guru Clinical manage concurrent studies effectively? Yes, Greenlight Guru Clinical is designed to support the management of multiple studies simultaneously. Its intuitive dashboard allows clinical teams to monitor the status, data, and compliance metrics of each study in real-time. This concurrent management capability reduces administrative overhead and helps ensure all studies progress efficiently without overlap or confusion.
Why is ISO 14155:2020 compliance important for EDC systems in medical device studies? ISO 14155:2020 sets the global standard for Good Clinical Practice (GCP) in medical device clinical investigations. EDC systems that comply with ISO 14155:2020 ensure that data collection, monitoring, and reporting align with these rigorous guidelines. This compliance reduces regulatory risks, helps ensure ethical study conduct, and facilitates smooth submission processes for device approvals.
About the company
In 2006, Jon Speer, a medical device engineer turned consultant, had the initial idea for Greenlight Guru, when he made a simple observation: paper-based quality management systems (QMS) are painful, risky, and inefficient. At the time, commercial QMS solutions had been available for nearly two decades, but only 30% of MedTech companies were actually using them. This observation led Jon and his co-founder, David DeRam, to develop Greenlight Guru. Today, with our powerful, intuitive solution, MedTech companies across the world can bring higher quality, life-changing products to market faster, more efficiently, and with less risk.