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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.
Description
Historically, managing clinical trials at investigator sites involved either the cumbersome task of maintaining numerous shared spreadsheets or investing in costly software that often did not fit the Australian context. MAISi represents a revolutionary shift in this landscape. Originating in 2001 as a data repository for clinical trials at a prominent hospital, MAISi has transformed into an advanced workflow application designed to streamline various functions within research units. Serving as a centralized database, MAISi efficiently organizes information related to studies and the corresponding business units that manage them. This structured approach enhances management decision-making capabilities. Individual staff members within each business unit can access specific data pertaining to their studies, patients, investigators, and study team members, while those with broader access rights, typically Financial Officers and System Administrators, can view comprehensive data across all units. Additionally, this streamlined access promotes collaboration and improves overall operational efficiency.
API Access
Has API
API Access
Has API
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
Greenlight Guru
Founded
2013
Country
Denmark
Website
www.greenlight.guru/clinical-electronic-data-capture-software
Vendor Details
Company Name
Agile Health Computing
Country
Australia
Website
www.agilehealthcomputing.com
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
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