Creation of TFLs and ADaM for clinical submissions involves a data-driven approach. It requires interpreting the content of the SAP document and translating it into technical expressions related to Study Data. These expressions define patient cohorts of interest, establish flags at the parameter/subject level, and create statistical routines. This presentation explores the use of executable search expressions and metadata specifications specifically customized for TFLs and ADaM, leveraging Indexed Study Data, along with automation facilitated by LLM.
Speaker: Raja Tummala, Chief Architect & President, Pointcross
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