Clinical data must now be submitted to the FDA in Study Data Tabulation Model (SDTM) format, a set of standards developed by CDISC and articulated through the SDTM Implementation Guide (IG) version 3.1.2. For a researcher who must submit large amounts of existing data, the FDA-mandated conversion of that data may require knowledge, tools and resources not immediately available to them. C-TASC, through our contract with the FDA, has developed considerable expertise in converting disparate sets of clinical data into an FDA-acceptable SDTM format. In fact, C-TASC is currently working for the FDA to assist in developing new standardized procedures for the receipt, processing and analysis of clinical trial data submissions. We have developed a largely automated, high-speed process within our StudyCTMS system, to convert disparate data files into FDA-acceptable SDTM format. We used this process in our work with the FDA to convert the data for over 20 studies in 2009. If you have study data you are preparing for submission to the FDA and need assistance in converting it to the SDTM standard for an expeditious review, or if you simply want assurance that your self-converted data will be accepted by the FDA, C-TASC can help.