Drug Evaluation Committee The "Utilization of Open Source Software and Points to Consider" and "OSS Utilization Questionnaire Report
Data Science Subcommittee
April 2023
In recent years, the use of open source software (OSS) such as R and Python has become increasingly active in the field of clinical development.
This task force conducted a questionnaire to understand the use of open source software in the clinical development work of member companies of the Data Science Division, and compiled it into the "OSS Usage Status Questionnaire Report.
In addition, as "Utilization of Open Source Software and Points to Keep in Mind," an introduction of open source software, its advantages and points to keep in mind when using it, as well as the management system and educational training that are considered necessary when assuming the use of open source software for approval application work, are introduced using R as a case study.
We hope this report will help you consider the use of open source software, especially R, in your company.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee FY2022 Ongoing Task Force 5
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