Glandon is a low-cost metadata repository built using semantic technologies for small and medium-size pharmaceutical companies to gain the benefit of using high-quality, standards-based, metadata in clinical studies.
Standards are not easy to work with and it is not getting any easier. There are multiple versions, updates, relationships between standards combined with the complexity of the clinical study lifecycle; we need all the help we can get. The desire is to make it easier for the user to work with standards focusing on what is important and getting the machine to do as much as possible to support the day-to-day work.
There is a fear that not all can benefit from standards without the right tools, tools that are built to use standards to the maximum and are able to move forward as standards improve. Therefore the tool is being developed as an open source development such that users can benefit without taking the significant risk of an expensive and complicated metadata project.
So as to be able to accommodate future change, change that will undoubtedly come, the tool is based on open-source semantic technologies. There is an increasing focus on such technologies within the standards community and at the FDA with the technology bringing the ability to add areas of new functionality in the future. As an example, there is a PhUSE project looking at placing the FDA regulations and guidance documents into an RDF form. When these become available it would be possible link the regulations with the standards. This would allow, as an example, domain rules from FDA guidance to be linked directly with the standard specification for that same domain.
More information on the features within the system can be found here.
For more detailed information please look at the following reference material:
|CDISC European Interchange, Basel, 2015||An explanation of Biomedical Concepts|
|PhUSE Conference, 2015, Vienna||Slides and paper from the PhUSE conference. Title “CDISC Standards and the Semantic Web”||Slides|
|CDISC European Interchange, 2016, Vienna||CDISC Standards: Assessing the Impact of Change||Blog Post|
|Vision||A document outlining the vision behind the development of the tool||Paper|
If you would like to know more please contact us using the email address:
contact <at> assero.co.uk