About SDTM-ETL
SDTM-ETL is a data change software from XML4Pharma designed for clinical trial data management. It provides features such as loading and validating an ODM file, loading the SDTM template and generating mappings for the DM domain, and generating mappings for the SV domain while creating global variables for reuse, as well as adding mappings for the Vital Signs domain. These capabilities help ensure accurate data preparation and compliance with regulatory requirements. The software supports efficient data integration and facilitates the creation of SDTM-compliant datasets. Key capabilities: loading and validating ODM files generating SDTM mappings creating global variables adding Vital Signs mappings supporting regulatory compliance Best for: clinical data managers and biostatisticians that need to change clinical trial data into SDTM format.
SDTM-ETL by XML4Pharma is a specialized ETL tool designed to transform clinical operational data into CDISC-compliant SDTM and SEND datasets, streamlining regulatory submissions without requiring statistical software like SAS. It includes preloaded SDTM/SEND templates, controlled terminology, and an intuitive workflow that simplifies the process for clinical data managers and programmers. The user interface is graphical and highly intuitive, featuring drag-and-drop mapping, guided wizards, and a step-by-step design that reduces manual coding. Its built-in data preview and automatic Define.xml generation make it efficient for users who may not have programming expertise but understand clinical data standards. Functionality-wise, SDTM-ETL focuses on the extraction, transformation, and loading of data from CDISC ODM sources into SDTM-compliant structures. It automates mapping processes, supports controlled terminology updates, generates relational and Define.xml files, and includes templates for both SDTM and SEND domains. These capabilities ensure accurate and repeatable transformations aligned with regulatory requirements. In terms of performance and reliability, the software is optimized for handling mid-to-large datasets efficiently. It offers consistent results across test and production environments, and its standalone setup reduces dependency on external frameworks.
Pros & Cons
- +It is significantly less expensive than a first-year SAS® basic windows Analytics license.
- +Eliminates the need for expensive SAS® software or knowledge of SAS/R programming.
- +The graphical user interface and wizards make mapping easy via drag-and-drop.
- +Mapping development time is reduced to just a few days by reusing existing mappings.
- +It supports all current CDISC standards and includes integrated CORE validation.
- −The source data must be in CDISC ODM format or transformed to it using another tool.
- −Mappings use the EasyXSL scripting language, which is a new layer to learn.
- −The EasyXSL language is a proprietary script working on top of XSLT.
- −Users must keep up with manuals and tutorials that are constantly being improved and extended.
- −As an alternative to established software, it may have a smaller user/support community in the industry.
Features
Key features
- SAS®-Free Operation
- The software does not require an expensive SAS® license or other statistical software like R to function.
- Automated define.xml Generation
- It automatically generates a submission-ready define.xml (2.0 or 2.1) and keeps it synchronized with the mapping.
- User-Friendly Graphical Interface (GUI)
- Mappings are created using an extremely intuitive interface with drag-and-drop and mouse-click actions.
- Mapping Reuse Capability
- Users can easily reuse mappings from previous studies, significantly reducing development time.
- Embedded CDISC CORE Validation
- It includes integrated CDISC CORE validation for generated SDTM/SEND datasets.
- Lowest Cost-Benefit Ratio
- It is positioned as the software with the lowest cost-highest benefit for creating SDTM/SEND datasets and define.xml in the industry.
Additional features
- Graphical User Interface (GUI)
- Provides an extremely user-friendly visual interface for mapping.
- Drag-and-Drop Mapping
- Allows creation of most mappings simply by dragging and dropping elements.
- Mapping Reuse
- Enables the ability to reuse mappings from other studies for new studies.
- Intelligent Wizards
- Uses wizards to provide define.xml details and generate scripts automatically without XML or Excel editing.
- ODM Input
- Uses CDISC ODM format files, which are exportable from most EDC systems, as the source data.
- Full CDISC Standard Support
- Supports all major SDTM versions (3.2 to 3.4) and SEND-IG versions (3.0 to 3.1.1), including extensions.
- CodeList Mapping Wizards
- Provides wizards for mapping codelists and generating valuelists.
- N
- 1 Mapping Generation: Supports combining multiple clinical data items to one SDTM variable (n:1 mapping).
- Hot Candidate Highlighting
- Highlights candidates for mapping according to ODM "SDSVarName" / "Alias=SDTM."
- Generate Output Formats
- Executes transformation to generate data in SAS-XPT, Dataset-JSON (1.1), or CSV format.
- Validate Against CDISC Library
- Allows validation of SDTM/SEND definitions against the CDISC Library.
- Automated SUPP-- Datasets
- Provides automated generation of SUPP-- datasets and records.
- Automated CO-Domain
- Provides automated generation of the Comments (CO) domain and records.
- Automated RELREC Datasets
- Provides automated generation of RELREC datasets and records.
- SQL Statement Creation
- Can create SQL statements to build a relational SDTM database.
- Database Population
- Can populate a relational SDTM database with generated SDTM records.
Pricing
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Interface languages
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About SDTM-ETL
SDTM-ETL is a data change software from XML4Pharma designed for clinical trial data management. It provides features such as loading and validating an ODM file, loading the SDTM template and generating mappings for the DM domain, and generating mappings for the SV domain while creating global variables for reuse, as well as adding mappings for the Vital Signs domain. These capabilities help ensure accurate data preparation and compliance with regulatory requirements. The software supports efficient data integration and facilitates the creation of SDTM-compliant datasets. Key capabilities: loading and validating ODM files generating SDTM mappings creating global variables adding Vital Signs mappings supporting regulatory compliance Best for: clinical data managers and biostatisticians that need to change clinical trial data into SDTM format.
SDTM-ETL Details
SDTM-ETL's In-App Market Place
Does SDTM-ETL have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
1
Mini Apps
N/A
Pricing Options
Accepted Payment Currencies
USD ($), EUR (€), GBP (£), JPY (¥), AUD ($), CAD ($), CHF (Fr), CNY (¥), SEK (kr), NZD ($)
Pros & Cons
- It is significantly less expensive than a first-year SAS® basic windows Analytics license.
- Eliminates the need for expensive SAS® software or knowledge of SAS/R programming.
- The graphical user interface and wizards make mapping easy via drag-and-drop.
- Mapping development time is reduced to just a few days by reusing existing mappings.
- It supports all current CDISC standards and includes integrated CORE validation.
- The source data must be in CDISC ODM format or transformed to it using another tool.
- Mappings use the EasyXSL scripting language, which is a new layer to learn.
- The EasyXSL language is a proprietary script working on top of XSLT.
- Users must keep up with manuals and tutorials that are constantly being improved and extended.
- As an alternative to established software, it may have a smaller user/support community in the industry.
SDTM-ETL's Support Options
Email Address
info@XML4Pharma.comSDTM-ETL's Alternatives
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