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Manufacturers of medical products such as drugs, vaccines, biologics and medical devices are required by law to report certain adverse reactions and complaints about their products in a timely fashion in all countries where the products are marketed or studied. As well as responding to these issues as they arise, manufacturers are increasingly looking to proactively identify safety issues by monitoring trends, identifying signals, and comparing products and incident rates with those of competitors.
Oracle AERS gives pharmaceutical companies the power to store and monitor adverse events encountered in clinical trials so that safety concerns can be addressed before a drug reaches the market. It is the only Safety system that is fully integrated with the leading CDM System - Oracle Clinical. Oracle AERS pulls adverse event information from the Oracle Clinical database to Oracle AERS, therefore preventing duplicate effort and possible database discrepancies. If the details of a clinical adverse event reach the Safety department before the data has been entered into Oracle Clinical, then the users can pick the patient and investigator information directly from the Oracle Clinical database, thus reducing possible discrepancies.
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