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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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Medidata
Veeva Vault
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medrio
OpenClinica
Oracle API Catalog
Oracle Clinical One
Prelude EDC
REDCap
Tremendous
Zelta

Integrations

Medidata
Veeva Vault
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medrio
OpenClinica
Oracle API Catalog
Oracle Clinical One
Prelude EDC
REDCap
Tremendous
Zelta

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

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
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

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

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