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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.

What is Astracore Clinical Trials?

Our platform for managing clinical trials is engineered to support virtually any form of controlled clinical trial, including randomized studies, and provides a range of randomization algorithms. This versatile software can be easily configured for both paper Clinical Report Forms (CRFs) and electronic CRFs (eCRFs). It is adept at capturing data in various formats and methods, adhering to the specific guidelines you set to maintain data integrity and quality assurance. The system allows for direct Electronic Data Capture (EDC) via eCRFs, or it can generate paper CRFs that can subsequently be entered into the system. Additionally, users can upload a variety of media including images, audio recordings, videos, and documents such as consent forms, with the only constraint being the available storage space. The platform incorporates Double Data Entry and offers thorough exception reporting to ensure accuracy. Furthermore, it features a mechanism to lock records once they have been validated, preventing any further modifications. This extensive functionality significantly bolsters the reliability of the data gathered throughout the trial, thus enhancing the overall research quality. Overall, our platform is designed to streamline the clinical trial process while ensuring the highest standards of data management and security.

Media

Media

Integrations Supported

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

Integrations Supported

API Availability

Has API

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

Denmark

Company Website

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

Company Facts

Organization Name

Astracore

Date Founded

2010

Company Location

Australia

Company Website

astracore.com/medical/clinical/

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

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

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