Greenlight Guru Clinical
4.3 out of 5 starsRatings and Reviews 12 Ratings
Ratings and Reviews 0 Ratings
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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.
What is Ennov CTMS?
Efficiently oversee every phase of clinical trials with Ennov’s all-inclusive Clinical Trial Management software. Each year, sponsors of clinical trials seek innovative strategies to enhance efficiency and minimize the expenses tied to their operations. By centralizing data, consistently tracking advancement, automating timelines, overseeing budgets, and delivering precise reporting and metrics, investigational site productivity can be significantly boosted. Ennov CTMS empowers trial sponsors and Contract Research Organizations (CROs) to manage all facets of trial operations from a unified platform, including investigator sites, participants, serious adverse events, deviations, inclusions, visit documentation, communication with trial subjects, management of investigational products, trial locations, and financial oversight. Study managers can monitor and plan their trials in real-time, enabling quicker and more informed decision-making. Additionally, the dashboard features of Ennov CTMS provide study teams with immediate access to analytics, enhancing quality, mitigating risks, and curtailing costs further. This comprehensive approach ultimately leads to a more streamlined clinical trial process, fostering greater success rates.
Integrations Supported
BSI CTMS
ChatGPT
Claude
Claude Duet
Claude for Legal
Cursor
Gemini
Medidata
API Availability
Has API
API Availability
Pricing Information
Pricing not provided
Free Trial Offered?
Pricing Information
Pricing not provided
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
Denmark
Company Website
www.greenlight.guru/clinical-electronic-data-capture-software
Company Facts
Organization Name
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com/clinical-trial-data-management-system/ctms-clinical-trial-management-software/
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
Categories and Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
Monitoring
Patient Database
Scheduling
Study Planning