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

Protocol First not only connects disparate locations and dismantles barriers in Clinical Research during the pandemic, but its offerings remain valuable during regular times as well. What was once viewed as optional technology has now become essential. Our solutions facilitate ongoing communication, enabling research not just to persist but to thrive and progress at an accelerated pace. Featuring a fully integrated remote monitoring tool equipped with automatic tagging, our system operates seamlessly with any EDC, anytime, and from any location. Protocol First prioritizes the integration of Sites, Sponsors, CROs, and various functional areas to create a cohesive research environment. We provide holistic solutions that tackle the numerous challenges faced in Clinical Research. The foundation of Protocol First is ensuring accuracy and proper placement of your data, which increasingly incorporates AI, NLP, and ML technologies. A critical component of utilizing AI effectively is establishing a robust structure for your data. The suite of software offered by Protocol First guarantees that data flows efficiently from patients to the FDA, maximizing the potential of data science and enhancing the overall research process. As we move forward, our commitment to innovation will continue to evolve, further amplifying our impact in the field.

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 

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 

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

Protocol First

Website

www.protocolfirst.com

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 No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Electronic Data Capture

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

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