adWATCH - AE

adWATCH – AE, developed by Atlant Systems, is a software tool designed to help pharmaceutical organizations manage and report adverse events that occur during clinical trials. It is intended for use by reporters at clinics, hospitals, and investigative sites, as well as researchers, physician investigators, Contract Research Organizations (CROs), clinical trial specialists, and other health professionals.

An adverse event is a negative or dangerous effect experienced by a patient caused by drugs and/or medical devices. Adverse event reporting requires tracking all medical complaint case information and generating MedWatch reports, CIOMS reports, and additional management reports. Traditionally, AERs have been filed manually with regulatory agencies and the FDA — a time-consuming and error-prone process. adWATCH – AE addresses this by allowing users to produce and file AERs in FDA-mandated MedWatch and/or CIOMS format by completing standardized electronic forms. The system can also file reports in predetermined databases and route them to the appropriate recipients, including the sponsor company and the relevant regulatory agency.

Features and Capabilities

• Mirrors the workflow of complaint processing from initial notification through investigation, analysis, and resolution.
• Automatically generates FDA-approved MedWatch, Baseline, and CIOMS reports from information already stored in the database.
• Includes a Customer Notification forms letter library that supports sending customized letters at predetermined times or on an as-needed basis during investigation and resolution.
• Supports timely customer feedback to enable quick responses to product quality issues.
• Includes a software validation database to assist with FDA-mandated requirements for initial validation and change control procedures.
• Enterprise-wide replication keeps information current across all locations worldwide.
• Allows remote users to participate in system functions via dial-up, intranet, or extranet connections.
• Provides an intuitive screen interface designed for ease of use.

Integration and Deployment

• Integrates with Protocol Manager, a clinical trial management system from Winchester Business Systems.
• Available on three platforms: Microsoft .NET, Cloud, and IBM Lotus Notes.