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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.
Description
cubeSAFETY is an advanced pharmacovigilance platform designed to assist safety teams in efficiently managing adverse-event reporting, regulatory submissions, and case processing in a compliant manner. It adheres to ICH E2B and various regional reporting standards, facilitating submissions to agencies like the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, while also automatically converting and formatting data for CIOMS and XML export. The platform boasts AI-driven medical coding suggestions, duplication detection, the capability to import CIOMS PDF files, and dynamic dashboards for real-time submission tracking. Additionally, it offers complete integration with other CRScube modules, including cubeCDMS. cubeSAFETY is crafted to enhance the safety-case entry process, guarantee superior data quality through embedded validation features, and streamline workflows for compliance with global regulatory requirements, all while decreasing manual labor and financial overhead. Ultimately, this innovative platform aims to redefine pharmacovigilance efficiency and accuracy across the industry.
API Access
Has API
API Access
Has API
Integrations
XML
cubeCDMS
cubeCTMS
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
Atlant Systems
Website
atlantsystems.com/atlant/solutions/atwatch-ae/
Vendor Details
Company Name
CRScube
Founded
2010
Country
South Korea
Website
www.crscube.io/solution/cubesafety
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management