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ease
features
design
support

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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

Prelude EDC is a web-based EDC (electronic data capture) solution that helps researchers and clinicians with clinical trial management. Key features include electronic data capture, data management, project management, custom fields, and compliance management. Prelude EDC comes with a drag-and-drop functionality, which helps administrators create electronic case report forms that are configured based on parameters such as entry fields, edit checks, calculations, and more. It allows users to streamline processes for searching, report generation, statistical reporting, and data querying, in order to optimize the preparation of datasets. Plus, the system comes with an in-built library of case report forms for producing reports on metrics such as patient demographics, deviations, adverse events, and study completion rates. Prelude EDC includes an XML export capability, allowing managers to import files into statistical analysis software. Its mobile application enables researchers to collect data and schedule daily, weekly, and monthly surveys.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

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

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Greenlight Guru Clinical
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

Prelude

Founded

2003

Country

United States

Website

www.PreludeEDC.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

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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