Average Ratings 12 Ratings

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Average Ratings 0 Ratings

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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

Introducing an integrated suite of professional tools designed to facilitate dynamic sharing of pre-clinical study data globally, featuring advanced capabilities and widely recognized industry standards. The Seralogix Study Manager™ platform seeks to create a standardized and efficient process for managing pre-clinical studies through a user-friendly interface. It caters to both individual researchers and large-scale research enterprises, harnessing powerful computational resources to simplify experimental design, data collection, and reporting. With this set of tools, you and your team can be assured of high data quality while reaping the advantages of immediate reporting. Successfully planning your experimental design can often feel overwhelming, but Seralogix Study Manager guides you through each step necessary to achieve the statistical rigor required for the success of your studies, ultimately transforming the way research is conducted. As you navigate this innovative platform, you'll discover how it can enhance collaboration and elevate the overall quality of research outcomes.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

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 

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 

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 No 
Live Rep (24/7) No 
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 No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

Denmark

Website

www.greenlight.guru/clinical-electronic-data-capture-software

Vendor Details

Company Name

Seralogix

Founded

2003

Country

United States

Website

www.seralogix.com/study-manager/

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

Electronic Data Capture

Audit Trail No 
CRF Tracking No 
Data Entry No 
Data Verification No 
Distributed Capture No 
Document Imaging No 
Document Indexing No 
Forms Management No 
Remote Capture No 
Study Management No 

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