The ODM Study and Define.xml Designer 2016

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Software from XML4Pharma for working with the CDISC standards

CDISC logo CDISC (Clinical Data Interchange Standards Consortium) is establishing new standards for exchange, storage and archival of clinical data.

The most important of these standards are the ODM (Operational Data Model), for the archival and exchange of clinical data between sponsors, CROs and Data Management Companies, and the SDTM (Submission Data Model)

Other standards are Lab (exchange of laboratory data), CRT-DDS (or define.xml) and ADaM (Analysis Dataset Model).

The ODM, Lab and CRT-DDS standards are written in XML

XML4Pharma has developed a number of software tools for working with CDISC ODM, Lab, SDTM and define.xml (CRT-DDS) standards. These products are especially interesting for Sponsors, CROs and Data Management Companies, as they save considerable time and money when working with the ODM and Lab standards. Also they can be incorporated into the products of technology vendors.

Our tools are not "take it or leave it" products, at the contrary. Our concept is to offer you a certain basic functionality for a very reasonable price (some of our tools are even free for CDISC members). We do however offer to adapt the software to your company´s needs and requirements, and if requested, deliver it as a plugin (including documentation) (e.g. as Java Bean). More information about these tools, pricing, our tailoring services, etc.., can be obtained from here.

These products are complementary to the consultancy services we deliver to sponsors, CROs, Data Management Companies, and Clinical Technology Vendors.

Our products :

SDTM-ETL: The user-friendly ODM to SDTM Mapping software
The ODM Study and Define.xml Designer 2016:
The software application to design and develop clinical studies in CDISC ODM format, and to generate and design CDISC Define.xml files
The define.xml Checker: Validating define.xml the easier and BETTER way
The ODMViewer (NEW Version 1.6 available) The CDISC ODM Checker The CDISC ODM Generator
The CDISC Lab ASCII to XML Converter The CDISC Lab Checker (ASCII or XML implementation) The ODM Reporter (PDF generator)

Our frontier breaking technology :

Automatic generation of eCRFs directly from the CDISC ODM


 SDTM-ETLTM

SDTM-ETLTM is a very user-friendly, visual software package to design and create mappings between CDISC ODM and CDISC SDTM, and to execute these mappings on your clinical data, generating SDTM datasets.
The software also allows to create an SDTM database in which the generated SDTM records can be stored.
Furthermore, the corresponding define.xml file is generated simultaneously.

More about SDTM-ETLTM


 The CDISC ODM Study and Define.xml Designer v. 2016

The CDISC ODM Study and Define.xml Designer v. 2016 is a tool to design and develop clinical studies in CDISC ODM format and to generate and design define.xml files. It reads the ODM XML-Schema or a Vendor Extension XML-Schema, and generates all tables, dialogs and wizards from that. The tool is extremely user-friendly: the user never needs to see any XML. The tool connects ODM and define.xml with SDTM: it knows everything about SDTM domains and variables of SDS 1.1 to 1.4 (SDTM-IG 3.1.1 to 3.2).

More about the CDISC ODM Study and Define.xml Designer v. 2016


The CDISC Define.xml Checker

The Define-XML Standard is one of the most established standards of CDISC, and also one of the most important, as it is required to be submitted by regulatory authorities such as the FDA and the PMDA.
The CDISC Define.xml Checker is a software package to validate your define.xml files against the standard and for internal consistency.
The software has been developed by Jozef Aerts, one of the main developers of both the define.xml 1.0 as 2.0 standard, and one of the most knowledgeable people concerning the Define-XML standard in the world.
It uses XML-Schema and Schematron (an "open rule" validation language) - the user can even switch on and off rule separately.
The software has been shown to be much better that the validator that is normally used by the FDA and PMDA (the latter reporting very many false positives).
As such, it is an indispensable software package for every sponsor that is submitting information to the FDA and PMDA using the define.xml standard, also as it allows to distinguish real conformity problems from false positive errors generated by the FDA and PMDA tools.

More about the CDISC Define.xml Checker


The ODM Viewer

The ODM Viewer is the first tool on the market to visualize CDISC ODM 1.2 or 1.3/1.3.1 files in a very user-friendly way. The data are visualized as HTML tables with easy navigation through the whole contents of the ODM file.
The ODM Viewer also allows to tabulate subsets of the data, e.g. all Demographics data of Subjects 1, 3, 7-10 where the Investigator was Jane Doe.

More about the ODMViewer (including screenshots)


The ODM Generator

The ODM Generator is a utility tool to transform "flat" data files (CSV, bar-delimited data files, exports from Excel, ...) into CDISC ODM files, including the generation of the metadata.
It is especially useful in combination with the
SDTM-ETL software when part of the data (such as lab data) is not available as CDISC ODM files.

More about the ODM Generator


The CDISC ODM Checker

The CDISC ODM Checker takes a CDISC ODM file and checks it for well-formedness and validity against the DTD or XML-Schema and (even more important) against the published standard (features that could not be incorporated into the DTD or Schema). This includes checking for consistency of the data (e.g. ClinicalData against Study MetaData).
If a violation against the standard is found, the application explains in well understandable language what is wrong, and gives good suggestions for reparing the violation.
This application is available for free to CDISC members.
It can also be made available as a module for incorporation into other software (on commercial basis).

More about the CDISC ODM Checker (including screenshots and demos)

: Now with Viewlet demos !

CDISC Lab ASCII to Lab XML Converter

This tool allows to transform CDISC Lab files in bar-delimited ASCII format into CDISC-Lab XML format. As such, this tools allows CROs that obtain Lab files in ASCII format to convert it into a better machine-readable format, and then to transform the Lab data into ODM format, and/or to store the Lab data in native XML databases.

More about the CDISC Lab ASCII to Lab XML Converter


The CDISCLabChecker

The CDISC Lab Checker is a tool for checking CDISC Lab files, either in XML format or in ASCII format, against the standard.
Both these tools have been implemented as server-side tools (you can already
use them free-of-charge at our application server), but they can also be made available as standalone applications (as Java application or Windows executable).
The XML version of the CDISCLabChecker has already been implemented at one of our NorthAmerican customers: it allows checking of all CDISC Lab files that are located on the server, and generates a validation report, and a log report (for 21CFR-11 reasons) for each of them. This ensures them that they really work CDISC-compliant.
More details about their implementation will soon be published.


ODM Reporter

This is a tool for on-the-fly generation of reports (in PDF) format from an ODM file.
The user can select which items of the ODM will be included in the output PDF file. Examples of generated reports of an early version of this reporting system can be found on our web page about "transforming XML data into PDF presentation".

More about the ODM Reporter (including screenshots)


Other tools

Do you need another tool for working with the CDISC set of standards ?
We have an enormous amount of experience with the CDISC ODM standard, and a good amount of experience with the XML implementation of the Lab standard. Furthermore, we are very experienced in designing and developing software for working with XML, mostly in Java, but also in Perl (CGI), PHP, C++.
So, if you need a tool to work with CDISC standards, or need advice for developing such tools or systems, do not hesitate to contact us.

Contact XML4Pharma
XML4Pharma, Schlossbergstr. 20, 78224 Singen, Germany. Phone: +49 7731 975044