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What is OpenClinica?

OpenClinica stands out as a prominent provider of software solutions for managing clinical data. Their robust tools are designed to enhance the compliance and efficiency of clinical trials. The main offerings from OpenClinica include OpenClinica Enterprise, OpenClinica Participate, and OpenClinica Randomize, which together facilitate a comprehensive approach to clinical data management. Each product addresses specific needs within the clinical research landscape, making them essential for successful trial execution. OpenClinica is an industry-leading platform that enables more efficient and effective clinical trials by providing a comprehensive range of tools for managing data, patient engagement, and recruitment. Key features include electronic data capture (EDC), patient-reported outcomes (ePRO), and fully automated eConsent, all designed to improve accuracy and streamline study workflows. The platform supports EHR-to-EDC integration, reducing manual errors and accelerating data collection. OpenClinica also offers robust reporting and data analysis tools, ensuring real-time insights into trial progress. With over 15,000 studies powered and more than three million patients involved, OpenClinica is trusted by life sciences organizations worldwide, from pharmaceutical companies to academic researchers and government bodies. Its seamless integration, user-friendly design, and comprehensive features make it an essential tool for advancing clinical research.

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.

Media

Media

Integrations Supported

BioGRID
ClinVigilant
Res_Q

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

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

OpenClinica

Date Founded

2006

Company Location

United States

Company Website

www.openclinica.com

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

Clinical Trial Management

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

Electronic Data Capture

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

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
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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