adWatch-AE (Safety Reporting) by Atlant Systems

Additional Details

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.