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Description

Built for medtech teams who can't afford clinical data problems. Greenlight Guru Clinical is the only EDC platform that starts with medical device requirements, not pharmaceutical ones. One validated system covers everything from study setup to adverse event reporting, backed by support that understands your regulatory context. Run your entire study from a single platform: Electronic Data Collection eCRF ePRO/eCOA eConsent Randomization (RTSM) PMCF Surveys Adverse Events Reporting Open API

Description

adWATCH - AE is a solution designed to aid pharmaceutical companies in handling and documenting adverse events that arise during clinical trials. It provides a quick and efficient way for reporters at clinics, hospitals, or investigative sites to create and oversee Adverse Event Reports (AERs), ensuring proper reporting to regulatory bodies and government organizations. An adverse effect refers to a harmful or undesirable reaction experienced by a patient due to medications or medical devices. The process of documenting adverse events necessitates thorough tracking of all medical complaint case details, which culminates in the creation of MedWatch reports, CIOMS reports, and other management documentation. With adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), clinical trial experts, and various health professionals can easily generate and submit AERs in compliance with FDA requirements, adhering to both MedWatch and CIOMS formats. This streamlined process not only enhances regulatory compliance but also improves patient safety oversight during clinical trials.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

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

Integrations

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

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

Denmark

Website

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

Vendor Details

Company Name

Atlant Systems

Website

atlantsystems.com/atlant/solutions/atwatch-ae/

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
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

Product Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

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