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Successful regulatory submissions to the U.S. Food and Drug Administration (FDA) rely not only on the quality of the data but also on how well CDISC data packages are structured, integrated, and documented. Incomplete or improperly formatted data packages can lead to delays, additional queries, or even rejection. Ensuring compliance with CDISC standards and aligning with FDA expectations is essential to streamline the review process. Proactive planning and thorough preparation can significantly reduce risks and increase the likelihood of approval.

For a number of years, Angelo Tinazzi, Senior Director, Statistical Programming at Cytel, has authored the blog series “The Good Data Submission Doctor” on data submission and data integration, such as an ISS or an ISE.

This newly revised ebook, which contains a collection of Angelo’s most critical insights on clinical data standards submission to the FDA, includes a new section summarizing the most relevant updates from the FDA Study Data Technical Conformance Guide over the last two years.

About Angelo

Angelo is a leading global expert on CDISC, particularly the Analysis Dataset Models (ADaM) and Study Data Tabulation Models (SDTM). His lively insights and deep knowledge of submission standards have enabled countless sponsors to have a seamless experience during one of the most
critical moments of drug development.

Angelo is a CDISC ADaM Authorized Instructor, member of the CDISC European Coordinating Committee for the period 2015–2025, and he has been recently nominated PHUSE-EU Connect Conference co-chair for the three-year period 2025–2027.