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The A3 Suite has been developed using semantic technologies for life sciences companies to gain the benefit of using high-quality, standards-based metadata in clinical studies.
A3 Suite Features and Benefits
The A3 Suite has now been established for two years (previously known as The Glandon Suite developed by A3 Informatics). It is designed and created by our team of experts at S-cubed to manage sponsor and CDISC standards in an intuitive and effective way. The Suite consists of the A3 MDR and the A3 Study Workbench and is built using graph technology, removing the need for managing your metadata using traditional methods (such as excel spreadsheets) which creates challenges for maintaining control or increasing scalability. Leveraging the graph technology breaks down the silos that currently affect the way industry works with data and provides seamless traceability.
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.
Meet Our Senior Team
Partner and Director of A3
Dave Iberson-Hurst joined S-cubed in 2019, as Partner and Director of A3 to develop the ground breaking A3 Suite to support the implementation of CDISC Standards. He founded Assero in 2003 to provide consultancy services to industry and develop products and solutions to bring global standards adoption closer to reality. Over the past 15 years, Dave has been instrumental in the development of industry standards for CDISC and has been regularly required to advise both the industry and its regulators on some of the challenges faced when implementing standards. In recent years, he has become a thought leader on the management of metadata within pharmaceutical companies to deliver one source of industry metadata that can be used for multiple purposes. Dave’s vision and ability to communicate the needs of a company to all those involved in the clinical research process has ensured that he is regularly asked to present at global industry events and contribute to a variety of articles.
Principal Consultant and CDISC Subject Matter Expert
Johannes has been working with CDISC Data Standards for the last 15 years. He is a qualified CDISC SDTM trainer and delivers training for CDISC in and around Copenhagen. He is also a Linked Data expert and is one of a handful of global experts on linked data and graph databases. A regular presenter at PhUSE and CDISC events, Johannes is an expert in ensuring your company can leverage the CDISC standards in the most efficient way possibly, whilst ensuring your data is accurate and submission ready.
Principal Consultant and CDISC Subject Matter Expert
Kirsten has worked with the CDISC standards for over 10 years, ranging from Protocol, CDASH, SDTM and ADaM. She has a vast range of experience working with and implementing CDISC standards and the associated change management processes. She is also a highly skilled project manager who can ensure that your CDISC implementation works with your current systems and any future installations. Kirsten is also part of the A3 Informatics team and is key to the development of future proofing your use of standards.
Principal Consultant and Data Standardisation Specialist
Dorte has worked with clinical and pre-clinical data management for over 12 years. She has specialised in developing and implementing CDISC aligned standards when collecting data providing an optimal set-up to facilitate subsequent data processing for submissions. Dorte has been working both with CDISC SDTM and SEND standards and has great experience of implementing data standards governance processes both within data management but also in different skill areas.
Dorte joined S-cubed aps in 2016.
Adam de Neergard
Partner and Director of Business Development, Software and Services
Adam brings 16 years’ experience with Sales, Sales Leadership and Business Development working in international IT companies like IBM, NNIT, SAS Institute and smaller startups. His primary focus throughout his career has been on building relationships with global Life Sciences organizations and helping digitalizing the industry.
CONTACT OUR TEAM
The Benefits of Using the A3 Suite
Companies using A3 Suite 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 A3 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)
- The A3 Suite can simplify the way you implement standards
- The A3 Suite will work with your current work flow and technology
- The A3 Suite can be implemented iteratively, to ensure you maintain productivity
Frequently Asked Questions
What is the A3 Suite?
The A3 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 use the A3 Suite from S-cubed?
S-cubed has 10 years of experience working with CDISC standards and we have encountered many of the challenges faced when implementing new systems and software. 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 A3 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.
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 A3 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 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.
What is a Biomedical Concept?
You can read all about Biomedical concepts and why we use them here: Understanding Biomedical Concepts
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Want to know more?
Do you still have questions about our software? Want to request a demo? Get in touch and we will be pleased to help.