Greenlight Guru Clinical

Greenlight Guru Clinical is an Electronic Data Capture (EDC) platform designed exclusively for medical device companies. Unlike pharma-first tools, every feature is purpose-built for MedTech, helping clinical teams, CROs, and device manufacturers generate reliable, compliant clinical data with confidence. Trusted by more than 1,000 medical device companies, the platform combines an easy-to-use, no-code interface with industry-leading customer service to keep trials on track and submission-ready.

Data collected on paper or spreadsheets is prone to errors and may be unusable in regulatory submissions. Greenlight Guru Clinical eliminates those errors by providing a single, validated platform that supports the full spectrum of medical device studies — from early feasibility and pivotal trials to post-market clinical follow-up (PMCF), registries, and PMA studies — all within one compliant system.

Core Platform Capabilities

• Electronic Data Collection (EDC): Real-time insight into study progress and data, with workflows that comply with FDA, EU MDR, and ISO 14155:2020 requirements.
• eCRF (Electronic Case Report Forms): Build forms in minutes using pre-validated question types. Clone, reuse, and improve forms to streamline study design and execution across multiple trials.
• ePRO/eCOA: Collect high-quality patient-reported outcome data with a patient-friendly interface that allows participants to securely fill out forms from their phone without downloading an app, improving response rates.
• eConsent: Simplify informed consent with an eConsent module compliant with 21 CFR Part 11 and EU standards for electronic signatures.
• Randomization and Trial Supply Management (RTSM): Handle randomization directly within the same platform, with support for both block and stratified randomization methods.
• PMCF Surveys: Meet post-market data requirements with dedicated PMCF study support, survey software, and registry-ready templates that simplify data collection.
• Adverse Event (AE/SAE) Reporting: A built-in safety module ensures timely and compliant adverse event reporting aligned with ISO 14155:2020. Customizable templates get teams started quickly while allowing full configuration to specific study needs.
• Two-Way API: Push and pull data securely with Greenlight Guru Clinical's leading-edge API, enabling integration with third-party applications for fast and secure data flow across platforms.

Key Benefits for Clinical Teams and CROs

• Built for MedTech, not pharma: Every feature is designed around the specific needs of medical device studies, without the complexity or customization required by pharma-centric tools.
• Fast implementation: Most teams are up and running in weeks rather than months, thanks to a no-code builder, reusable templates, and onboarding provided by medical device experts.
• Unrivaled data visibility: Set up studies in minutes and access real-time views of data in an intuitive, modern platform.
• Fewer errors, cleaner data: User-friendly forms enforce response rules and eliminate potential data entry errors, reducing time spent on data cleaning.
• Site-friendly design: The simple, intuitive interface requires little to no training for study sites, even those with limited technical experience, supporting better site relationships and smoother collaboration.
• Reusable study configurations: Clone forms, workflows, and full study configurations to save time and ensure consistency across multiple trials.
• CRO and sponsor collaboration: Role-based access controls and activity logs allow CROs and sponsors to collaborate securely within the platform while maintaining data integrity and compliance.

Compliance and Validation

• Fully aligned with ISO 14155:2020, 21 CFR Part 11, and GDPR.
• Built-in audit trails, Part 11-compliant electronic signatures, and role-based access controls ensure data is always submission-ready.
• The platform is pre-validated, with complete system validation documentation provided so teams can skip lengthy setup processes and remain inspection-ready.
• Supports both pre-market and post-market evidence needs, including early feasibility, pivotal trials, PMA studies, post-market surveillance, registries, and PMCF surveys.

Onboarding, Training, and Support

• All customers receive hands-on onboarding with dedicated Clinical Gurus who are experienced in MedTech workflows.
• Access to an online academy and ongoing support covering study builds, user roles, and best practices.
• Training is tailored specifically to medical device clinical operations, not generic eClinical workflows.

Greenlight Guru Clinical integrates seamlessly with the broader Greenlight Guru platform, which also includes an AI-powered eQMS for quality management and modern product development tools — providing a connected solution across the entire medical device product lifecycle. The platform is suitable for pre-market and post-market teams, CROs, enterprise organizations, and SiMD/SaMD developers alike.