Once your treatment or device is approved for market, it is likely that the FDA will request your company to conduct a Phase IV study to gather additional information about the safety and toxicity of our newly marketed treatment or device. StudyCTMS is an ideal Trial Management System to collect this source of information, with web designs that allow large numbers of individuals to enter data on simple forms in a structure that is readily interpretable by FDA officials. Again, as part of C-TASC interaction with the FDA, C-TASC staff are currently developing methodologies and analyses procedures for collecting and reporting data from the Adverse Event Reporting System (AERS). As such, they have a thorough understanding of how your information will be processed at the FDA.