Average Ratings 0 Ratings
Average Ratings 12 Ratings
Description
We believe that outcomes are paramount, which distinguishes ALPHADAS and the Instem Clinical team from the competition. We acknowledge the dedication and resources our clients invest in selecting ALPHADAS to enhance their clinical operations, and we strive to ensure they experience a Day 1 Return on Investment. Our unparalleled expertise in early-phase trials, backed by over a century of combined practical experience within our Clinical team, guarantees that clients will navigate the transformation of their early-phase clinical trials with ease and efficiency. ALPHADAS presents a powerful end-to-end software solution that accelerates crucial drug development decision-making and offers operational cost savings across the organization. Moreover, our team is committed to continuous improvement, ensuring that we adapt and evolve alongside our clients' needs.
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
No
API Access
Has API
Yes
Integrations
BSI CTMS
No
ChatGPT
No
Claude
No
Cursor
No
Gemini
No
Medidata
No
Oracle Clinical One
No
Prelude EDC
No
Tremendous
No
Veeva Vault
No
Integrations
BSI CTMS
Yes
ChatGPT
Yes
Claude
Yes
Cursor
Yes
Gemini
Yes
Medidata
Yes
Oracle Clinical One
Yes
Prelude EDC
Yes
Tremendous
Yes
Veeva Vault
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
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)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Instem Group
Founded
1995
Country
United States
Website
www.instem.com/solutions/application-areas/clinical.php
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
Denmark
Website
www.greenlight.guru/clinical-electronic-data-capture-software
Product Features
Electronic Data Capture
Audit Trail
Yes
CRF Tracking
Yes
Data Entry
Yes
Data Verification
Yes
Distributed Capture
No
Document Imaging
No
Document Indexing
No
Forms Management
No
Remote Capture
Yes
Study Management
Yes
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