When submitting data to the US Food and Drug Administration, maintaining a steady line of communications is essential. Frequent technical discussions can help ensure sufficiently thorough guidance from the agency and reduce snags in the process made by time-consuming corrections. In a new ebook, Cytel’s Senior Director of Statistical Programming, Angelo Tinazzi, shares his insights on enhancing the data submission process.
According to Cytel, “Angelo is a leading global expert on CDISC Analysis Dataset Models (ADaM) and Study Data Tabulation Models (SDTM). His lively insights and deep knowledge of submission standards have ensured that countless sponsors have encountered a seamless experience, during one of the most critical moments of a clinical trial.”
To register and download the free ebook, click here.
(Source: Cytel, May 12th, 2022)