|
|
||||
| Home | Services | CDISC | Software | About us |
Example Implementation in Software
Quality and custom CORE rules derived from the CDISC "SDTM Dataset Specializations"
Knowledge and Technology Transfer
CORE is developed in close cooperation with the FDA, and is expected to soon replace the validation software currently used by the FDA. It has also already been introduced to the PMDA and to the NMPA.
Besides being completely "open", CORE has a number of advantages over other submission validation software:
XML4Pharma has been extremely actively involved in the development of CORE, especially in the implementation in YAML of hundreds of rules for SEND, FDA Business Rules and SDTM, and in the testing of many of the rules developed by other volunteers. As such we can say we are "expert rule developers".
For example, we generated "quality rules" starting from the "SDTM Dataset Specializations", which are essentially "SDTM implementations" of the "CDISC Biomedical Concepts".
We are also making these "SDTM Dataset Specialization custom" rules available to the industry.
Several examples can be found here.
As the experts in CDISC CORE, we offer the following services:
Although CORE installation is not difficult, we have customers who want us to take care of this, either on location or remote.
We can then also take care of implementing updates when these become available from CDISC.
One of the major advantages of CORE is that one can add own (quality) rules to the CORE Engine. It is even possible to set up sets of CORE rules as a 'custom standard', e.g. one set per sponsor (for CROs), project, or even study.
As a specialist in the development of CORE rules, we develop 'custom' rules for our customers, organize them in 'custom standards', and version them.
You may also be interested in our presentation at the CDISC European Interchange 2026 in Milano on "Developing Custom Rules for CDISC-CORE"
CORE becomes most valuable when integrated in the systems and pipelines of sponsors and CROs.
We already helped several companies reaching this goal.
There are cases that in order to be able to add a new custom rule, a new CORE function is needed.
For CDISC and FDA rules, this is done by CDISC Python developers and volunteers, who then do a "Github pull request" to have the new Python function being added to the base Python code.
For functions needed for "custom rules", this will not always have the highest priority at CDISC. In such cases, we can develop the necessary Python code for you, add the unit tests for it, and so generate a "custom version" of CORE.
At the same time, we then ask CDISC to also have that function in the next version of CORE, so that it becomes available to everyone, and thus avoid "Software branching spaghetti".
We have implemented or integrated CORE in different software packages of our own offerings (such as the SDTM-ETL mapping software), but also integrated it in the pipelines of some of our customers.
The screenshot below comes from our open source "Smart Submission Dataset Viewer",
which is freely available from SourceForge.
Starting from the "CDISC SDTM Dataset Specializations", we derived 6996 "custom" CORE rules and added those the CDISC CORE Engine, and then implemented this is a number of our software tools, such as the "SDTM-ETL" mapping software.
These "custom" rules highly contribute to the quality of SDTM submissions, as these go far beyond what "standard" CORE rules, and especially Pinnacle21 can offer.
Some examples:
If you would like to obtain a copy of these "SDTM Dataset Specializations" (DSS) "custom" CORE rules, and/or help with implementation in your existing CORE installation, just drop us an e-mail. For the DSS set of rules itself, there is a small cost though (we are not a charity organization).
We find knowledge and technology transfer important. We are not one of these consultants or technology providers that provide you with a black-box solution.
At the contrary, during an assignment, we learn your people understanding the CDISC standards and how to work with them.
When developing a software solution specific for your company, we provide the source code of that software together with the full software documentation.
