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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.

Media

Media

Integrations Supported

Integrations Supported

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

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

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

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