Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • Qualio Reviews & Ratings
    884 Ratings
    Company Website
  • RegDesk Reviews & Ratings
    19 Ratings
    Company Website
  • Code-Cube.io Reviews & Ratings
    7 Ratings
    Company Website
  • Jotform Reviews & Ratings
    8,469 Ratings
    Company Website
  • XpertCoding Reviews & Ratings
    42 Ratings
    Company Website
  • LegalEdge Reviews & Ratings
    17 Ratings
    Company Website
  • SDS Manager Reviews & Ratings
    4 Ratings
    Company Website
  • HSI Donesafe Reviews & Ratings
    172 Ratings
    Company Website
  • Nasdaq Metrio Reviews & Ratings
    14 Ratings
    Company Website
  • MedRight Reviews & Ratings
    22 Ratings
    Company Website

What is cubeSAFETY?

cubeSAFETY is a cutting-edge pharmacovigilance solution that aids safety teams in the effective management of adverse event reporting, regulatory submissions, and case processing while ensuring compliance. It complies with ICH E2B as well as various regional reporting guidelines, enabling submissions to regulatory bodies such as the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, and it can automatically convert and format data for CIOMS and XML exports. The platform features AI-enhanced medical coding recommendations, duplication detection, the ability to import CIOMS PDF files, and dynamic dashboards for tracking submissions in real-time. Furthermore, it provides seamless integration with other CRScube modules, including cubeCDMS. Designed to improve the safety case entry process, cubeSAFETY ensures exceptional data quality through built-in validation tools and streamlines workflows to meet global regulatory standards, all while reducing manual efforts and costs. In essence, this innovative platform aspires to transform the landscape of pharmacovigilance by enhancing both efficiency and accuracy in the industry, making it a valuable asset for safety teams worldwide.

What is adWATCH?

adWATCH - AE serves as a comprehensive solution for pharmaceutical companies to effectively manage and document adverse events that may occur throughout clinical trials. It offers a rapid and streamlined method for individuals at clinics, hospitals, or research sites to generate and monitor Adverse Event Reports (AERs), ensuring that all necessary information is accurately relayed to regulatory authorities and governmental entities. An adverse event is defined as any harmful or negative reaction a patient experiences as a result of medications or medical devices. The meticulous documentation of these adverse events requires detailed tracking of all medical case specifics, which leads to the production of essential reports such as MedWatch and CIOMS. With the implementation of adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), and various healthcare professionals can efficiently create and submit AERs that comply with FDA standards, following the formats established by both MedWatch and CIOMS. This organized approach not only bolsters adherence to regulatory guidelines but also significantly enhances the oversight of patient safety during the course of clinical trials. Furthermore, the tool's user-friendly interface facilitates collaboration among multiple stakeholders, contributing to a more transparent and accountable research environment.

Media

Media

Integrations Supported

XML
cubeCDMS
cubeCTMS

Integrations Supported

XML
cubeCDMS
cubeCTMS

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

CRScube

Date Founded

2010

Company Location

South Korea

Company Website

www.crscube.io/solution/cubesafety

Company Facts

Organization Name

Atlant Systems

Company Website

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

Categories and Features

Categories and Features

CAPA

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

Popular Alternatives

SafetyEasy Reviews & Ratings

SafetyEasy

AB Cube

Popular Alternatives

Evidex Reviews & Ratings

Evidex

Advera Health Analytics
Thrana Safety Database Reviews & Ratings

Thrana Safety Database

Thrana Softech
PharmaPendium Reviews & Ratings

PharmaPendium

Elsevier
Clienvo eTMF Reviews & Ratings

Clienvo eTMF

Clinevo