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The Glandon MDR can today manage sponsor and CDISC standards including terminology, forms (CDASH) and SDTM. In addition, the system manages Biomedical Concepts to allow for a flexible way to build more standardised forms and capture data consistently across studies. The system provides version control, giving instant access to changes across versions and provides impact analysis processing when new versions are created.
The Glandon Study Workbench is a tool for specifying what data to collect and report for a study. The latest version integrates study build and define.xml functionality. The tool utilises the metadata from the Glandon MDR and the relationships between the metadata. The user can build a Schedule of Assessments (SoA), create study CRFs and aCRFs, export definitions to EDC systems using ALS or ODM and create a define.xml for the study

Vision

To support the move away from a variable-based world to one based on real-world concepts and the data’s natural form with associated relationships  (Biomedical Concepts). This move is needed to address issues faced by industry in the use of data standards today.

Method

Use semantic web and graph technologies to provide the underlying model.

The use of these technologies allows for new areas to be easily accommodated and updates made without major disruption to existing work. Thus, as standards evolve, so can the tools without disrupting users.

Lifecycle

The Glandon Suite will support the full clinical lifecycle with an MDR that supports tools across that lifecycle. It utilises an open system using an API that allows for individual tools.

Today the system supports study setup. During Q4 of 2018 support for ADaM and in 2019 support for basic protocol definitions to be introduced.

Glandon MDR

The Glandon MDR is a Metadata Repository handling CDISC Terminology (version control and management), Biomedical Concepts, Forms and SDTM  Model, Implementation Guides and Custom Domains
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Glandon Study Workbench

A tool that takes definitions from the MDR and allows studies to be constructed and then exported in ODM and ALS formats suitable for loading by EDC tools.
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LATEST BLOGS

SDTM Mapping in a Linked Data World

SDTM Mapping in a Linked Data World

04/09/2018

by Kirsten Langendorf - CDISC Subject Matter Expert   SDTM, Tables and Linked Data It can be a tricky communication task to convey the linked graph data approach for handling SDTM data, to an audience used to making SDTM in a table-based approach (SAS and excel...