C-TASC is proud to announce the addition of Theresa Straut, a former Regulatory Compliance Officer with Quintiles, as their newest addition to the staff at C-TASC. Theresa has been actively involved in many regulatory submissions to the FDA, including writing all required regulatory documents from pre-IND meetings to submissions of NDAs/BLAs and aNDAs. 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.