Greenlight Guru Clinical (formerly SMART-TRIAL) is a comprehensive Electronic Data Capture (EDC) software platform specifically engineered for the MedTech industry. It provides a single, compliant solution for the collection and management of all clinical evidence, safety, and performance data related to medical device studies. The platform is optimized to meet the unique needs of medical device studies, eliminating the need for coding, complex setup, or expensive, pharma-centric features. It ensures compliance from the outset, being pre-validated per FDA and ISO 14155:2020 standards, and includes built-in support for EU MDR requirements, alongside 13 ready-to-use and customizable compliance document templates. Greenlight Guru Clinical streamlines and simplifies data collection, effectively eliminating medical device compliance risks and significantly cutting down on clinical test timelines, as evidenced by user testimonials. Its intuitive design, including a 3-step study builder with drag-and-drop elements, fosters clarity, speed, and efficiency in clinical research workflows. The platform supports complex study designs, including multi-indication device studies and dynamic visits and treatments, making it a versatile toolbox for MedTech clinical data collection.

Features & Benefits

• Optimized for MedTech Studies
  • Software is specifically designed for medical device studies, requiring no coding, stressful setup, or unnecessary pharma-centric features.
• Regulatory Compliance & Validation
  • Ensures compliance from the start with built-in ISO 14155:2020, EU MDR, and FDA requirements, plus 13 ready-to-use and customizable compliance document templates.
• Multi-Indication Study Support
  • Facilitates easy adjustments to study designs according to different countries' requirements and EC approvals.
• Dynamic Visit & Treatment Management
  • Supports multiple activations for any visit event, accommodating study subjects requiring one or many treatments with the device.
• Intuitive 3-Step Study Builder
  • Enables rapid study setup in as little as 90 seconds using intuitive drag-and-drop elements, form validation, and customizable protocol designs, allowing for easy adjustment and reuse.
• Customizable eCRF
  • Allows users to design electronic Case Report Forms (eCRF) based on unique study requirements, with no limits on complexity.
• ePRO/eCOA Data Collection
  • Provides secure SMS and Email data collection for Electronic Patient Reported Outcomes (ePRO) and Electronic Clinical Outcome Assessments (eCOA), enhancing user experience and increasing response rates, adherence, and data quality.
• Pre-validated Post-Market Surveys
  • Offers out-of-the-box GCP-compliant surveys for collecting dynamic data to comply with EU MDR PMCF or FDA Post-Approval requirements.
• GCP Compliant Ad-Hoc Data Collection (Cases)
  • Features a mobile-first tool for clinician-friendly, compliant ad-hoc data entry of high-quality patient data in post-market settings.
• Extensible Add-ons
  • Expands study capabilities with additional tools like eConsent, randomization, custom study dashboards, and external system integrations.