Fujitsu Limited today announced that it has developed tsClinical for SDTM Automation, a solution for pharmaceutical companies that automatically converts electronic study data to the standardized Study Data Tabulation Model (SDTM) format. SDTM Automation is available for pharmaceutical companies in Japan as of today.
This solution can automatically convert the submission data to the standard SDTM format that pharmaceutical companies must submit to regulatory agencies when applying for approval of a new drug, which is promoted by the Clinical Data Interchange Standards Consortium (CDISC), an organization that establishes global standards for clinical study data. By automatically converting the submission data, this solution prevents issues caused by human error or misunderstanding of the standard in manual conversion, reducing the cost required to convert electronic study data to SDTM format and improving the quality of the data.
The Pharmaceuticals and Medical Devices Agency (PMDA), a regulatory agency in Japan, will require all applications to be submitted electronically in SDTM format starting in April 2020. By offering this solution, Fujitsu is providing world-leading support for the automatic generation of SDTM data (patent pending). This will quickly resolve issues that many pharmaceutical companies may face, such as ensuring the quality of SDTM data, securing human resources to generate the data, and minimizing data generation costs, while also supporting PMDA in their efforts to promote the use of clinical data, contributing to new drug development in Japan.