The Theradex biostatistical and programming staff has broad experience in the planning and conducting of analyses for phase I, II, and III multinational studies. Theradex biostatisticians are also accustomed to ongoing dialogues with regulatory authorities to ensure concurrence in the appropriateness of analyses. These dialogues continue up through preparations for market approval. Additionally, the biostatistical and programming staff assist the medical writing and regulatory groups in the preparation of regulatory submissions and incorporate the necessary data tabulations for further regulatory analysis and graphical displays.