Greenlight Guru Clinical
4.3 out of 5 starsRatings and Reviews 0 Ratings
Ratings and Reviews 12 Ratings
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What is Signant Health?
Signant Health stands as a global frontrunner in evidence generation, dedicated to revolutionizing the clinical trial landscape by engaging patients in their own settings and reimagining the path to validation. They provide a comprehensive suite of clinical technology solutions that encompasses electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and an integrated eClinical platform. Their offerings also include patient engagement tools like an intuitive app, eConsent for effective informed consent practices, and telehealth capabilities. Furthermore, Signant Health specializes in clinical data and analytics services, which involve COA data analysis along with the synthesis and interpretation of data. With over thirty years of experience, the company has been crucial in facilitating numerous clinical trials and has significantly contributed to hundreds of drug approvals, solidifying their position as a dependable partner for sponsors and CROs who aim to deliver high-quality data for informed decision-making and regulatory filing. Their unwavering dedication to innovation is continuously molding the future of clinical research, ensuring that advancements benefit both patients and the medical community at large.
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.
Integrations Supported
BSI CTMS
ChatGPT
Claude
Claude Duet
Claude for Legal
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
API Availability
API Availability
Has API
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Free Trial Offered?
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Webinars
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Signant Health
Company Location
United States
Company Website
signanthealth.com
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
Denmark
Company Website
www.greenlight.guru/clinical-electronic-data-capture-software
Categories and Features
Clinical Trial Management
Not specified
Electronic Data Capture
Not specified
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