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.
Single source of adverse event and complaint data
Easy to use interface
Powerful case management features
Query all adverse event data from one simple interface
Submission Wizard helps create regulatory submissions easily and quickly
Produce regulatory reports from standard templates for regulations like MedWatch 3500a, CIOMS I, NDA Periodic, PSUR, IND Safety Update, Yellow Card, BfArM, MedWatch for Device, VAERS and many more
Monitor safety issues and incidents over time using audit trail and product tracking
