Once data are collected and ready to be submitted to the FDA, it is important to organize those data in such a way that they can be rapidly consumed and analyzed by FDA staff so the decision can be made about whether your biomarker, treatment or device will be approved for sale in the United States. C-TASC has over 7 million dollars in contracts with the FDA, and we are currently working with the FDA investigators to determine the standard data configuration for future data submissions to this agency. Currently, data must arrive in the standard data tabulation methodology (SDTM), developed by CDISC and adopted by the FDA. C-TASC staff have developed a SDTM conversion module, which can easily convert your data into SDTM formatted data, so that it can be rapidly consumed and analyzed at the FDA. C-TASC staff have converted over 70 datasets for the FDA as one of its contracts. Currently, C-TASC staff are capable of converting your dataset to SDTM data in little more then one month of time. Let us help you with your next data submission to the FDA.