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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.
 SDTM-ETL: The user-friendly ODM to SDTM Mapping software |
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| The ODM Study Designer v.1.1: a tool to design and develop clinical studies in CDISC ODM format |
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| The define.xml Checker: Validating define.xml the easy way |
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| The ODMViewer (NEW Version 1.1 available) | The CDISC ODM Checker | The CDISC Lab ASCII to XML Converter |
| The CDISC Lab Checker (ASCII or XML implementation) | The ODM Database generator | The ODM Reporter (PDF generator) |
Automatic generation of eCRFs directly from the CDISC ODM
SDTM-ETLTMSDTM-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.
The ODM Study DesignerThe ODM Study Designer is a tool to design and develop clinical studies in CDISC ODM format. It reads the ODM XML-Schema or a Vendor Extension XML-Schema, and generates all tables, dialogs and wizards from that. The tool is very user-friendly: the user never sees any XML. The tool is also SDTM-ready: SDTM information can be added to the ODM from lists of domains and variable names from the SDTM 1.1 / SDS 3.1.
More about the ODM Study Designer
The Case Report Tabulation Data Definition Standard (CRT-DDS), better know as define.xml
is one of the newer standards of CDISC, and one of the most important, as it the first of a small series for submissions to the FDA in CDISC XML format.
The CDISC Define.xml Checker is a validation software package to validate your define.xml files against the standard and for internal consistency.
As such, it is an indispensable software package for every sponsor that is submitting information to the FDA using the define.xml standard.
More about the CDISC Define.xml Checker
The ODM Viewer is the first tool on the market to visualize CDISC ODM 1.2 or 1.3 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 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 !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 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.
Essentially, the MetaDataVersion section in the ODM contains all necessary information for a CRO about which data will have to be delivered to the sponsor, and in which format. Therefore, we constructed a tool which translates the data in the MetaDataVersion section into a set of SQL statements for database table generation.
This enables CROs and Data Management Companies to generate all necessary tables for a study within a few seconds, starting from a (partial) ODM file delivered by the sponsor.More about the Database Table Generator (including screenshots)
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)
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.
