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Average Ratings 12 Ratings

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Description

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

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.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Medidata Yes 
Veeva Vault Yes 
BSI CTMS No 
ChatGPT No 
Claude No 
Cursor No 
Gemini No 
Medrio Yes 
OpenClinica Yes 
Oracle API Catalog Yes 
Oracle Clinical One No 
Prelude EDC No 
REDCap Yes 
Tremendous No 
Zelta Yes 

Integrations

Medidata Yes 
Veeva Vault Yes 
BSI CTMS Yes 
ChatGPT Yes 
Claude Yes 
Cursor Yes 
Gemini Yes 
Medrio No 
OpenClinica No 
Oracle API Catalog No 
Oracle Clinical One Yes 
Prelude EDC Yes 
REDCap No 
Tremendous Yes 
Zelta No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
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) Yes 
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 No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

ClinVigilant

Founded

2017

Country

United Kingdom

Website

www.clinvigilant.com

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

Denmark

Website

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

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance Yes 
Document Management Yes 
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 No 
Document Imaging No 
Document Indexing No 
Forms Management Yes 
Remote Capture Yes 
Study Management Yes 

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 

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