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Average Ratings 0 Ratings

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ease
features
design
support

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Description

ExtraView serves as a comprehensive software solution designed for enterprises, focusing on business process management and global quality management systems, particularly in areas like CAPA, adverse event reporting, food safety, bug tracking, change management, and customer support. Users can choose between pre-built solutions or tailor their own specifications to meet unique needs. It can be deployed as a cloud service or installed on local servers, making it versatile for various operational environments. The platform is user-friendly, allowing for easy configuration while also supporting the implementation of fully validated systems for incident management, CAPA, adverse event reporting, root cause analysis, clinical trial data management, and food safety initiatives. Additionally, it facilitates the establishment of bug-tracking, customer support, requirements management, and other vital issue-tracking systems. A noteworthy aspect is that many users can benefit from a robust, free downloadable version of the software. Furthermore, financial organizations often utilize ExtraView to enhance their systems for auditing, ensuring corporate governance, and managing risks effectively. This adaptability makes it an essential tool for a wide range of industries looking to streamline their workflow processes.

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

No details available.

Integrations

No details available.

Pricing Details

$400 one-time payment
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

ExtraView

Founded

1999

Country

United States

Website

www.extraview.com

Vendor Details

Company Name

Atlant Systems

Website

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

Product Features

Bug Tracking

Backlog Management
Filtering
Issue Tracking
Release Management
Task Management
Ticket Management
Workflow Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Issue Tracking

Assignment Management
Dashboard
Escalation Management
Issue Auditing
Issue Scheduling
Knowledge Base
Project Management
Recurring Issues
Scheduling
Task Management

Workflow Management

Access Controls/Permissions
Approval Process Control
Business Process Automation
Calendar Management
Compliance Tracking
Configurable Workflow
Customizable Dashboard
Document Management
Forms Management
Graphical Workflow Editor
Mobile Access
No-Code
Task Management
Third Party Integrations
Workflow Configuration

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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