We offer a range of services around our tools to help organisations solve the challenges of implementing and using CDISC Standards. We can support your implementation of CDISC Standards across the clinical lifecycle.

Our global leading software solutions are supported by the CDISC Subject Matter experts at S-cubed who can:

  • Ensure you have consistency across studies

  • Provide impact analysis of changes in versions and terminology

  • Provide control of your standards

  • Produce aCRFs and define.xml automatically based on your standards

  • Improve the quality of your SDTM

  • Export electronic specifications for SDTM ready for import

  • Assist you with your legacy data converting to SDTM and ADaM

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Manage Internal and CDISC Standards

We offer a standards management service and training in CDISC Standards. We can offer version management and change control services using the Glandon MDR.

Create CDISC Compliant CRF for Studies

Using the Glandon MDR and Study Workbench, CRF creation can be decentralised and still maintain adherence to CDISC Standards.

Create an Annotated CRF for a Study

Using the Glandon MDR and Study Workbench we can easily assist you to create annotated CRFs by a simple click of a button; a task that typically is resource demanding and semi-manual.

Create EDC Specification

We can create export files that can be read by an EDC system (ALS and ODM). We can help you maintain control over the differences and how they affect deliverables.

Create SDTM Data Sets

Using our experts and software, you can avoid error prone mapping. You will have clear traceability. Using biomedical concepts, you have consistent, yet flexible, SDTM creation.

Create Define.xml

We can ensure that you have traceability to SDTM.  Define.xml can be generated before any subject data is present. From study set up, the define.xml is made by a  simple click of a button.

The Benefits of Using Our Services and Software

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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
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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
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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 Services?

Our team have over 20 Years experience of supporting sponsors with implementing CDISC Standards. We have developed robust working practices and our partner company S-cubed are recognised as CDISC registered solutions providers. Our suite of tools has been designed with CDISC Standards and 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.

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 you help me convert my legacy data?

Absolutely. You can choose to use our tools to support converting your legacy data to machine readable formats and ensure you have consistency across studies.

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.

WANT TO KNOW MORE?

If we didn’t answer all of your questions, feel free to drop us a line anytime.