Average Ratings 12 Ratings

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Average Ratings 0 Ratings

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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

Achieve a comprehensive understanding of your research operations by utilizing a robust and standardized clinical trial management system that has been developed in partnership with prominent academic medical and cancer centers. Streamline billing designation processes to promote uniformity across various teams and systems. Enhance your budgeting strategies, ensure accurate routing of charges, and perform more effective audits and monitoring of billing compliance. This integrated approach provides deep visibility and insight into all elements of clinical research, particularly in financial management, thanks to collaboration with elite research institutions. Moreover, by connecting OnCore with your existing electronic medical records (EMR), including seamless integrations with Epic and Cerner, you can significantly boost patient safety, minimize redundant data entry, improve billing compliance, and elevate overall operational efficiency. Ultimately, this system not only simplifies processes but also fosters a more effective research environment.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

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 
XpertCoding No 

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 
XpertCoding Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
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 Yes 
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) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

Denmark

Website

www.greenlight.guru/clinical-electronic-data-capture-software

Vendor Details

Company Name

Advarra

Founded

1993

Country

United States

Website

www.advarra.com/solutions-for/clinical-trial-sites/oncore-enterprise-research-ctms/

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 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management Yes 
Electronic Data Capture Yes 
Enrollment Management Yes 
HIPAA Compliant Yes 
Monitoring Yes 
Patient Database Yes 
Recruiting Management Yes 
Scheduling Yes 
Study Planning Yes 

Electronic Data Capture

Audit Trail Yes 
CRF Tracking Yes 
Data Entry Yes 
Data Verification Yes 
Distributed Capture No 
Document Imaging Yes 
Document Indexing Yes 
Forms Management Yes 
Remote Capture No 
Study Management Yes 

Medical Lab

Audit Trail No 
Data Analysis Auditing No 
Data Security Yes 
EMR Interface Yes 
Fax Management No 
Lab Instrument Interface No 
Multi-Location Printing Yes 
Online Instrumentation No 
Physician Test Panels No 
Procedure-Based Billing No 
Sample Tracking Yes 

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