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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 Qualineo?

Qualineo is a software-as-a-service solution that specializes in quality and risk management, specifically designed for healthcare, social care, and medical imaging sectors. It supports a range of facilities, including nursing homes, hospitals, clinics, laboratories, and home-care services, by simplifying their quality management workflows. The platform provides a comprehensive set of tools which include document management, monitoring and reporting of adverse incidents, plans for corrective and preventive measures, as well as conducting audits and self-assessments. By leveraging Qualineo, teams can effectively consolidate quality-related documents, track essential actions, and thoroughly prepare for evaluations and inspections. Moreover, it incorporates an AI assistant intended to boost efficiency in quality-related tasks. This platform is tailored for use by administrators, quality professionals, and care teams, with workflows specifically crafted to promote continuous quality improvement across the entire organization. By implementing this solution, care facilities can reliably uphold high standards of quality and compliance, leading to improved patient and client outcomes. Ultimately, Qualineo serves as a vital resource for organizations striving to enhance their operational excellence in the health and social care sectors.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Online Training

Training Options

Not specified

Company Facts

Organization Name

Atlant Systems

Company Website

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

Company Facts

Organization Name

Qualineo

Date Founded

2017

Company Location

France

Company Website

www.qualineo.io

Categories and Features

CAPA

Not specified

Drug Discovery

Not specified

Categories and Features

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