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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 LifeSphere Medical Affairs?

LifeSphere Medical Affairs, developed by ArisGlobal, is a cloud-based solution designed to enhance efficiency, ensure regulatory compliance, and foster collaboration among medical affairs professionals. It offers a unified workspace that merges medical information management with safety and quality assurance systems, facilitating thorough automation and real-time data sharing. This platform streamlines the process of collecting and managing medical inquiries across multiple channels, automates the processing of product complaints and adverse events, and ensures compliance with ever-evolving global regulatory standards. Equipped with advanced analytics and reporting features, it provides crucial insights that support data-driven decision-making and improve patient outcomes. LifeSphere Medical Affairs is tailored to be both scalable and customizable, catering to the unique needs of organizations of all sizes. Additionally, it enables medical teams to navigate effectively through a rapidly changing regulatory environment while enhancing their overall operational performance. This adaptability is particularly vital as the medical landscape continues to evolve, ensuring that teams remain responsive and proactive.

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

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Atlant Systems

Company Website

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

Company Facts

Organization Name

ArisGlobal

Date Founded

1987

Company Location

United States

Company Website

www.arisglobal.com/lifesphere/medical-affairs/

Categories and Features

CAPA

Not specified

Drug Discovery

Not specified

Categories and Features

Medical Affairs

Not specified

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