C-TASC staff will be able to develop a clinical plan for your treatment or device that has a time- tested structure for achieving a successful submission to the FDA. In addition to this knowledge, C-TASC has over 6 million dollars in contracts with the FDA to assist in developing data standards for SDTM and ADaM submissions for FDA review. Since C-TASC staff are actively involved in developing these standards, you can be assured that your data files will be appropriately prepared and ready for FDA review at the first submission.