The CDISC Study Data Tabulation Model (SDTM) is a mandatory standard for regulatory submissions of clinical trial data. This paper introduces an effective tool to automate the entire process of migration to SDTM standardization. The automation is performed based on some functionality oriented meta-data and logic checks. The solution is characterized by an easy to use and simple interface that can be used by anyone. The robust architecture is designed to handle multiple studies irrespective of the study phase and therapeutic areas. This comes with a scalable system design that supports adapting to different versions of the CDISC standards very easily. The implementation of this automated approach aims at a significant reduction of the time and resource requirement for an SDTM migration task. This approach can be further extended to accomplish ADaM migration.
BizNET, a complete suite for clinical trial management has easy end-to-end mapping for study database. It allows the CDISC defined XML standard and enables data managers to generate CDISC SDTM compliant datasets for reporting to various regulatory bodies in a standardized and compliant means.
Easy flow and use of CDISC standards from eCRF design to data collection, cleaning and finally exporting of the entire data to tabulation for analyses. Application is beneficial in terms of cutting cost and time followed up by improving data integrity with proper data mapping.