Allows for a define.xml file to be built based on either the study definition, an existing file or with limited source information. Uses the MDR to aid the user into populating the define.xml.
The Benefits of Using the Glandon Suite
Companies using Glandon will gain control and full benefit of using CDISC Standards
- Efficient standards management supporting version management and identification of changes.
- Easy to apply standards during study build ensuring cross-trial standardisation.
- Immediate impact assessment when CDISC standards change
- Better traceability throughout data flow
- Using Glandon MDR an electronic produced annotated CRF and define.xml is created by the push of a button
Better control of CDISC standards delivers further benefits, including
- Increased use of standard programs on trial data, including data quality checks
- Less effort required to streamline data for submission
- Avoidance of submission delays
The CDISC Business Case demonstrates why standards need to be implemented
- You can read the various business cases from CDISC on their website (login is required)
- Glandon can simplify the way you implement standards
- Glandon will work with your current work flow and technology
- Glandon can work iteratively with you, to ensure productivity
Frequently Asked Questions
Why use A3 Informatics?
Our suite of tools has been designed with real world work in mind. We know that your company cannot stop working on drug development to implement costly IT projects. The Glandon Suite is designed to be implemented in an iterative manner; you can choose what you need, when you need it. We have built our products to ensure there is minimal impact on your day to day work. Alternatively, you can choose to use us as a service, where we can demonstrate the power of the tools and ensure that you are able to implement the CDISC Standards.
What is the Glandon Suite?
The Glandon Suite comprises an MDR (Metadata Repository) handing Sponsor-defined and CDISC Terminology, Biomedical Concepts, Forms and the SDTM (Study Data Tabulation) Model, Implementation Guides and Custom Domains. Additionally, there are tools to support the clinical research process, including a Study Workbench, with a study build and Define.xml modules.
Why build it on CDISC Standards?
CDISC Standards are required by the FDA and PMDA for submission data. We want to ensure that you can get your product to submission as easily as possible.
Can I choose to just use the Glandon MDR?
Absolutely. We have a variety of models of implementation that you can choose. Or you can use our consultants and they will use the tools to support you with a variety of services.
What is a Biomedical Concept?
You can read all about Biomedical concepts and why we use them here: Understanding Biomedical Concepts
What support do you provide?
We have expert consultants and a range of materials to help you. We can work on site or remotely dependent on your needs and we offer a full range of supporting documentation for the tools. We also have established and recognised CDISC trainers as part of our team, who can support your staff throughout implementation.