adWATCH - AE gives the medical professional a fast and effective means of generating and managing Adverse Event Reporting (AERs).
adWATCH - AE helps pharmaceutical organizations manage and report adverse events that occur during clinical trials. adWATCH - AE gives the reporter at a clinic, hospital, or investigative site a fast and effective means of generating and managing Adverse Event Reports (AERs) and reporting to the regulatory departments and government agencies.
An adverse effect is a negative or dangerous effect experienced by a patient and caused by drugs and/or medical devices. Adverse event reporting requires the tracking of all medical complaint case information, resulting in the generation of MedWatch reports, CIOMS reports and additional reports for management.
AERs have traditionally been filed with the respective regulatory agencies and the FDA, manually, in a time consuming and error-prone process - often leaving out the sponsor drug or device company.
adWATCH - AE allows researchers, physician investigators, Contract Research Organizations (CROs), clinical trial specialists, and other health professionals to produce and file AERs in the FDA mandated MedWatch and/or CIOMS format. They accomplish this task by simply filling in standardized forms, electronically on user-friendly screens. adWATCH - AE not only generates the reports, but can also file them in predetermined databases and direct them to the attention of the proper recipients - the sponsor company and respective regulatory agency.
adWATCH - AE integrates seamlessly with Protocol Manager, clinical trial management system from Winchester Business Systems.
Features and Benefits
- adWATCH - AE mirrors the workflow of complaint processing from initial notification through investigation, analysis, and resolution.
- adWATCH - AE automatically generates the FDA-approved MedWatch, Baseline, and CIOMS reports from information already in the database.
- The Customer Notification forms letter library provides the ability to send customized letters at predetermined times or on an as-needed basis during the investigation and resolution.
- adWATCH - AE provides the ability to respond quickly to product quality issues by providing timely customer feedback.
- adWATCH - AE includes a software validation database to assist with FDA-mandated requirements for initial validation and change control procedures.
- Enterprise-wide replication ensures up-to-the-minute information is available across all locations, worldwide
- adWATCH - AE allows remote users to participate in many functions of the system via dial-up, intranet, or extranet.
- An intuitive look and feel to screens makes using adWATCH - AE simple and easy to use.
ADWATCH - AE is available on 3 different platforms:
Microsoft .NET Platform
IBM Lotus Notes Platform
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