Average Ratings 12 Ratings
Average Ratings 0 Ratings
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.
Description
Clinical One RTSM is capable of accommodating various randomization strategies, ranging from the most straightforward to highly intricate studies, all without requiring any programming or coding, which consequently reduces the duration of user acceptance testing. You can take charge of your study with self-service configurations, allowing you to develop a study in just a matter of days rather than weeks. Additionally, you can assess the drug inventory status and make real-time adjustments without needing to consult the vendor, thereby avoiding unnecessary costs and change requests. By implementing changes swiftly, you can eliminate expenses associated with change requests and prevent delays, enabling you to launch your studies almost instantaneously. This platform stands out as the only one that genuinely integrates individuals, processes, and data to streamline and expedite the future of clinical trials. Moreover, the inclusion of virtual components in clinical trials enhances patient engagement and significantly elevates the quality of trial data. To keep pace with the rapidly evolving landscape, it is essential to adopt transformative digital strategies that facilitate quicker study initiations, harmonize data from diverse sources, and optimize workflow efficiency. Such advancements are pivotal for the successful execution of modern clinical research initiatives.
API Access
Has API
Yes
API Access
Has API
No
Integrations
BSI CTMS
Yes
ChatGPT
Yes
Claude
Yes
Cursor
Yes
Gemini
Yes
Greenlight Guru Clinical
No
Medidata
Yes
Oracle Clinical One
Yes
Prelude EDC
Yes
Tremendous
Yes
Integrations
BSI CTMS
No
ChatGPT
No
Claude
No
Cursor
No
Gemini
No
Greenlight Guru Clinical
Yes
Medidata
No
Oracle Clinical One
No
Prelude EDC
No
Tremendous
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
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
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)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
Denmark
Website
www.greenlight.guru/clinical-electronic-data-capture-software
Vendor Details
Company Name
Oracle
Founded
1977
Country
United States
Website
www.oracle.com/life-sciences/clinical-trials/clinical-one-randomization-supplies-management/
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
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
No
Document Management
No
Electronic Data Capture
No
Enrollment Management
No
HIPAA Compliant
No
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No