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What is LibreClinica?

The authentic open-source electronic data capture (EDC) system designed for clinical research was the result of a joint effort by volunteers from various fields, such as academia, clinical research services, and information technology. Presently, this initiative finds application in numerous academic institutions, hospitals, and newly established companies or startups, reflecting its broad acceptance and versatility in the industry. This cooperative strategy has not only driven innovation but has also significantly enhanced the efficiency of data collection processes in clinical studies. As a result, researchers can now access a more streamlined and effective method to gather and analyze clinical data.

What is Greenlight Guru Clinical?

Medical device and diagnostics companies running clinical studies are often stuck configuring EDC software that was built for pharmaceutical trials and never designed around FDA, EU MDR, IVDR, or ISO 14155 requirements. Greenlight Guru Clinical solves that by being the only electronic data capture (EDC) system built from the ground up for medtech, so teams aren't reworking someone else's pharma template to fit a device study. Designed exclusively for medtech, Greenlight Guru Clinical combines an easy to use clinical data platform with industry leading customer service, so teams generate reliable, compliant clinical data with confidence. Get a single, validated platform covering the full lifecycle of a device or diagnostics study, including: Electronic Data Collection and eCRF design, with GCP compliant structures and built in audit trails ePRO/eCOA for patient and clinician reported outcomes, collected in person or remotely on any device eConsent for compliant, auditable enrollment Randomization (RTSM) for controlled and comparative studies PMCF Surveys for post market clinical follow up under EU MDR Adverse Events Reporting built into the platform Leading-edge, open API for connecting study data to other clinical or quality systems Greenlight Guru Clinical supports pre-market clinical investigations, post-market surveillance studies, registries, and human factors testing, and is used by both device and diagnostics manufacturers and by contract research organizations (CROs) that specialize in medtech. A validation package is included with every product update, removing the ongoing burden of software revalidation from the quality team. Every customer also gets a dedicated customer success manager with real medtech experience, not a generalist software account rep. For manufacturers already on Greenlight Guru's quality management system (QMS), Clinical extends into one connected platform spanning quality, product development, and clinical evidence.

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Integrations Supported

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

Integrations Supported

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

API Availability

Has API

API Availability

Has API

Pricing Information

Free
Open source
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

LibreClinica

Date Founded

2019

Company Website

libreclinica.org

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

Denmark

Company Website

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

Categories and Features

Electronic Data Capture

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

Categories and 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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