Average Ratings 0 Ratings
Average Ratings 12 Ratings
Description
BrightInsight significantly shortens the time it takes for clients to bring their digital health solutions to market, which encompasses apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across various therapeutic domains. By utilizing a pre-built and validated digital health platform that adheres to a comprehensive Quality Management System, BrightInsight eliminates the need for time-consuming and complex custom implementations while ensuring compliance with global security, privacy, and regulatory standards. For example, we assisted Roche in launching a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in just six months in Europe, and we expedited a remote patient platform for a Top 10 Biopharma company from the initial project kickoff to market readiness in under a year. Our expertise lies in the development and maintenance of regulated digital health products for both the biopharma and medtech sectors, having achieved multiple successful commercial launches within the past year alone. This proficiency enables us to respond swiftly to industry demands while maintaining the highest standards of quality and compliance.
Description
Greenlight Guru Clinical is the only electronic data capture (EDC) system built specifically for medical device and diagnostics companies. While most EDC platforms were designed for pharmaceutical trials and later adapted for medtech, Greenlight Guru Clinical starts from device and diagnostic requirements: FDA regulations, EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and ISO 14155 for clinical investigations.
Designed exclusively for medtech, it combines an easy to use clinical data platform with industry leading customer service, helping teams generate reliable, compliant clinical data with confidence.
Get a single, validated platform with everything needed to run a medical device or diagnostics study, including:
Electronic Data Collection and eCRF, built with pre validated question types that can be cloned and reused across studies
ePRO/eCOA, electronic patient and clinician reported outcomes collected in person or remotely
eConsent
Randomization (RTSM)
PMCF Surveys, purpose built for post market clinical follow up under EU MDR
Adverse Events Reporting
Leading edge, open API for connecting study data to other clinical or quality systems
Greenlight Guru Clinical is used by medical device and diagnostics manufacturers running pre-market clinical investigations and post-market surveillance studies, and by contract research organizations (CROs) that specialize in medtech. Every customer gets a dedicated customer success manager with real medtech experience and a validation package included with every product update. For teams that also use Greenlight Guru's quality management system (QMS), Clinical connects directly into one platform covering quality, product development, and clinical evidence.
API Access
Has API
No
API Access
Has API
Yes
Integrations
BSI CTMS
No
ChatGPT
No
Claude
No
Cursor
No
Gemini
No
Medidata
No
Oracle Clinical One
No
Prelude EDC
No
Tremendous
No
Veeva Vault
No
Integrations
BSI CTMS
Yes
ChatGPT
Yes
Claude
Yes
Cursor
Yes
Gemini
Yes
Medidata
Yes
Oracle Clinical One
Yes
Prelude EDC
Yes
Tremendous
Yes
Veeva Vault
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
BrightInsight
Founded
2017
Country
United States
Website
brightinsight.com
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
Denmark
Website
www.greenlight.guru/clinical-electronic-data-capture-software
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
No
Healthcare CRM
Audience Targeting
Yes
Campaign Management
Yes
Marketing Automation
No
Medical History Records
Yes
Patient Communications
Yes
Patient Management
Yes
Physician Management
Yes
Predictive Analytics
Yes
IoT
Application Development
No
Big Data Analytics
Yes
Configuration Management
Yes
Connectivity Management
Yes
Data Collection
No
Data Management
Yes
Device Management
Yes
Performance Management
No
Prototyping
No
Visualization
No
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
No
Electronic Data Capture
Yes
Enrollment Management
Yes
HIPAA Compliant
Yes
Monitoring
Yes
Patient Database
No
Recruiting Management
No
Scheduling
Yes
Study Planning
Yes
Electronic Data Capture
Audit Trail
Yes
CRF Tracking
Yes
Data Entry
Yes
Data Verification
Yes
Distributed Capture
Yes
Document Imaging
Yes
Document Indexing
Yes
Forms Management
Yes
Remote Capture
Yes
Study Management
Yes