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.

No buzz words . . . just real systems . . . tailored to fit your business . . . to manage drug development

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