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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.

What is MediaLab Intelligent Quality Engine (IQE)?

MediaLab's Intelligent Quality Engine (IQE) solution is engineered to provide efficient automation for managing non-conforming events in laboratories. By eliminating reliance on traditional paper-based manual investigations and corrective and preventive action (CAPA) procedures, IQE not only reduces costs but also enhances your quality improvement initiatives. This innovative system ensures compliance with corrective and preventive action standards recognized by organizations such as CAP, the Joint Commission, ISO, and various other accreditation entities. As a result, you will experience a more efficient and streamlined process that aids in meeting regulatory requirements. Begin by utilizing our pre-designed online form templates or take the opportunity to customize your own. Empower your employees to report issues as soon as they arise, and MediaLab will efficiently guide your event through every stage of the management lifecycle, including initial reporting, risk assessment, resolution, and evaluations of change effectiveness. Additionally, your existing processes and forms will integrate seamlessly with IQE, enhancing your laboratory's operational efficiency and compliance efforts. Ultimately, adopting IQE leads to a more proactive approach to quality management.

Media

Media

Integrations Supported

Integrations Supported

MediaLab Document Control

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing is an annual subscription based on the number of seats. Request a quote to get an accurate price estimation!
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
Chromebook
Linux

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Atlant Systems

Company Website

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

Company Facts

Organization Name

MediaLab

Date Founded

1995

Company Location

United States

Company Website

www.medialab.com/iqe-for-laboratories

Categories and Features

CAPA

Not specified

Drug Discovery

Not specified

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

Lab Automation

Not specified

LIMS

Audit Trail
Certificates of Analysis
Data Import / Export
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Workflow Management

Root Cause Analysis

Not specified

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