About Greenlight Guru Clinical
Greenlight Guru Clinical is an EDC software platform from Greenlight Guru that supports the medical device industry. It combines product development, clinical management, and a customizable process to help collect high-quality clinical data. Designed specifically for engineers and trusted by auditors, this platform allows teams to focus on product advancements rather than administrative tasks. With a user-friendly interface, Greenlight Guru Clinical simplifies the data capture process while ensuring compliance with industry standards. Key capabilities: Electronic Data Capture Customizable workflows Clinical trial management Compliance tracking Data quality assurance Best for: MedTech companies that need to collect accurate clinical data efficiently.
Greenlight Guru Clinical (GGC) is an advanced Electronic Data Capture (EDC) platform created specifically for the MedTech industry, distinguishing it from generic EDC systems designed primarily for pharmaceutical research. Its primary goal is to help medical device companies collect, manage, and analyze high-quality clinical data that is fully compliant with global regulatory requirements. By combining tools like ePRO, eConsent, adverse event reporting, and randomization into a single validated environment, the platform streamlines the entire clinical study lifecycle, from feasibility through post-market clinical follow-up. This specialization makes it particularly valuable for device manufacturers that need to meet the strict standards of ISO 14155:2020 and FDA 21 CFR Part 11 without additional customization. The user interface is widely praised for being modern, intuitive, and straightforward, with a drag-and-drop study builder that allows researchers to quickly create case report forms and configure studies without coding knowledge. This simplicity reduces setup times and minimizes training needs for clinical staff, making the system accessible even for teams with limited technical expertise.
Pros & Cons
- +Quick and easy setup
- +User-friendly and intuitive interface
- +Efficient data entry and navigation
- +Simplifies documentation in clinical trials
- +Clean and modern layout
- +Easy to toggle between panes and tabs
- +Minimal training required for site staff
- −Limited customization for specific study needs
- −Occasional website slowness
- −Repetitive fields in clinical forms
- −Queries not easily visible or editable
- −Frequent sign-in required after inactivity
- −No support for multiple open windows
- −Limited filter options for CRFs
Features
Key features
- MedTech-Specific Design
- This platform is purpose-built for medical device studies, ensuring every feature is tailored to the unique needs of the MedTech industry, unlike general pharma-first tools.
- No-Code, Fast Implementation
- You can set up studies in minutes using a no-code, validated solution, which significantly accelerates study start-up times.
- Compliant Data Collection
- The software helps you collect high-quality, reliable, and compliant clinical data with workflows that adhere to strict regulations like FDA, EU MDR, and ISO 14155:2020.
- Unrivaled Real-time Visibility
- The platform provides real-time views and insights into study progress and data in an intuitive and modern dashboard.
- Comprehensive eClinical Platform
- It is a single, validated system that offers a wide range of tools for every stage of a clinical trial, from early feasibility to post-market surveillance.
- Extensible Platform
- The platform is highly extensible, with add-on modules for features like randomization, eConsent, and a powerful API for two-way communication.
Additional features
- Electronic Data Collection (EDC)
- A tool to collect clinical data electronically.
- ePRO/eCOA
- Gathers electronic patient-reported outcomes and clinical outcome assessments.
- eConsent
- A module for obtaining electronic consent from study participants.
- Randomization (RTSM)
- A tool to manage patient randomization in a study.
- PMCF Surveys
- Supports surveys for post-market clinical follow-up.
- Adverse Events Reporting
- A feature for reporting and tracking adverse events.
- Leading-edge API
- An API that allows for two-way communication to push and pull data.
- Real-time Data Visibility
- Provides real-time insight into study progress and data.
- Built for MedTech
- Every feature is designed specifically for medical device studies, not pharmaceuticals.
- Validated Solution
- The system is pre-validated to meet regulatory standards, saving time and effort.
- No-Code Study Builder
- Allows for setting up studies in minutes without coding.
- Reusable Forms
- You can reuse existing forms and studies across multiple trials.
- Compliant Workflows
- Workflows align with regulations such as FDA, EU MDR, and ISO 14155:2020.
- Audit Trails
- Provides detailed audit trails to ensure data integrity.
- Part 11-Compliant e-signatures
- Supports electronic signatures that comply with 21 CFR Part 11.
- Data Quality Tools
- Features user-friendly forms that enforce response rules to eliminate errors.
- User-Friendly for Sites
- Designed to be simple and reliable for site-level staff to use.
- Ad-Hoc Data Collection
- A feature for collecting data on a case-by-case basis.
- Clinical Trial Management
- Manages all clinical data collection in one system for any type of study, from early feasibility to registries.
Pricing
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About Greenlight Guru Clinical
Greenlight Guru Clinical is an EDC software platform from Greenlight Guru that supports the medical device industry. It combines product development, clinical management, and a customizable process to help collect high-quality clinical data. Designed specifically for engineers and trusted by auditors, this platform allows teams to focus on product advancements rather than administrative tasks. With a user-friendly interface, Greenlight Guru Clinical simplifies the data capture process while ensuring compliance with industry standards. Key capabilities: Electronic Data Capture Customizable workflows Clinical trial management Compliance tracking Data quality assurance Best for: MedTech companies that need to collect accurate clinical data efficiently.
Greenlight Guru Clinical Details
Greenlight Guru Clinical's In-App Market Place
Does Greenlight Guru Clinical have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
1
Mini Apps
No
Pricing Options
Accepted Payment Currencies
USD ($), EUR (€), GBP (£)
Pros & Cons
- Quick and easy setup
- User-friendly and intuitive interface
- Efficient data entry and navigation
- Simplifies documentation in clinical trials
- Clean and modern layout
- Easy to toggle between panes and tabs
- Minimal training required for site staff
- Limited customization for specific study needs
- Occasional website slowness
- Repetitive fields in clinical forms
- Queries not easily visible or editable
- Frequent sign-in required after inactivity
- No support for multiple open windows
- Limited filter options for CRFs
Greenlight Guru Clinical's Support Options
Email Address
clinical.support@greenlight.guruGreenlight Guru Clinical's Alternatives
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