| From CDISC-compliant data transformation to submission package generation—enhancing regulatory readiness
JNPMEDI, a clinical trial consulting and platform company led by CEO KwunHo Jeong, has announced the launch of ‘Maven Converter’, an automated clinical data transformation solution based on the CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model) standard. This End-to-End system is designed to convert raw data generated during clinical trials into SDTM format and generate regulatory submission-ready packages.
‘Maven Converter' supports a No-Code environment that allows users to import raw data collected from various Electronic Data Capture (EDC) systems and convert it into SDTM-compliant datasets with just a few clicks. By enabling easy configuration of complex rules and structures and minimizing repetitive tasks, the solution significantly improves both the efficiency and accuracy of CDISC-based workflows.
Key features include dataset and variable setup aligned with the latest SDTM Implementation Guide (SDTMIG) versions, unit conversion, and controlled terminology (SDTM CT) management. It also offers a flexible data flow that supports automatic re-conversion when raw data is updated. Furthermore, the system automatically generates metadata based on the Define-XML format and provides intuitive CRF labeling with real-time synchronization to the metadata, helping to reduce the manual workload.
In the validation phase, ‘Maven Converter’ utilizes the CDISC CORE Engine to assess data quality. The system then automatically generates a submission-ready package, including Define-XML files and validation reports with issue listings. Users can download the complete package as a compressed file with a single click, ensuring a consistent and streamlined process from data transformation to submission.
“Maven Converter addresses the limitations of manual, labor-intensive CDISC processes with a solution that is fast, simple, and user-friendly,” said Product Manager MiAe Lee of JNPMEDI. “We are committed to supporting clinical trial professionals in efficiently preparing regulatory submissions with our technology-driven approach.”
In addition to SDTM, JNPMEDI offers expertise in CDISC standards across the board, including ADaM (Analysis Data Model), Define-XML, and Controlled Terminology. The company continues to expand its clinical data solution offerings through its proprietary Maven Clinical Cloud platform.
| From CDISC-compliant data transformation to submission package generation—enhancing regulatory readiness
JNPMEDI, a clinical trial consulting and platform company led by CEO KwunHo Jeong, has announced the launch of ‘Maven Converter’, an automated clinical data transformation solution based on the CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model) standard. This End-to-End system is designed to convert raw data generated during clinical trials into SDTM format and generate regulatory submission-ready packages.
‘Maven Converter' supports a No-Code environment that allows users to import raw data collected from various Electronic Data Capture (EDC) systems and convert it into SDTM-compliant datasets with just a few clicks. By enabling easy configuration of complex rules and structures and minimizing repetitive tasks, the solution significantly improves both the efficiency and accuracy of CDISC-based workflows.
Key features include dataset and variable setup aligned with the latest SDTM Implementation Guide (SDTMIG) versions, unit conversion, and controlled terminology (SDTM CT) management. It also offers a flexible data flow that supports automatic re-conversion when raw data is updated. Furthermore, the system automatically generates metadata based on the Define-XML format and provides intuitive CRF labeling with real-time synchronization to the metadata, helping to reduce the manual workload.
In the validation phase, ‘Maven Converter’ utilizes the CDISC CORE Engine to assess data quality. The system then automatically generates a submission-ready package, including Define-XML files and validation reports with issue listings. Users can download the complete package as a compressed file with a single click, ensuring a consistent and streamlined process from data transformation to submission.
“Maven Converter addresses the limitations of manual, labor-intensive CDISC processes with a solution that is fast, simple, and user-friendly,” said Product Manager MiAe Lee of JNPMEDI. “We are committed to supporting clinical trial professionals in efficiently preparing regulatory submissions with our technology-driven approach.”
In addition to SDTM, JNPMEDI offers expertise in CDISC standards across the board, including ADaM (Analysis Data Model), Define-XML, and Controlled Terminology. The company continues to expand its clinical data solution offerings through its proprietary Maven Clinical Cloud platform.