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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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

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
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Healthcare CRM

Audience Targeting
Campaign Management
Marketing Automation
Medical History Records
Patient Communications
Patient Management
Physician Management
Predictive Analytics

IoT

Application Development
Big Data Analytics
Configuration Management
Connectivity Management
Data Collection
Data Management
Device Management
Performance Management
Prototyping
Visualization

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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