A3 Study Workbench Our Study Workbench utilises the power of the A3 MDR and integrates study build and define.xml functionality

The A3 Study Workbench is a tool for specifying what data to collect and report for a study.  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

A3 Study Workbench Features & Benefits

Study Setup

Study setup specifying Schedule of assessment -SoA (selecting CRFs) based on MDR standard Forms.

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Generate CRFs

Generate CRF and annotated CRFs for the study

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Study Setup Exports

Allows for exporting SoA in ODM and ALS formats for quicker EDC setup.

Export Formats

Supports JSON, ALS and ODM export formats

Define.xml from study build

Generate define.xml based on a study build

Define.xml from MDR

Generate define.xml on (master) models in MDR

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Export Define.xml

Export define.xml files in all versions (1.0.0, 2.0.0 & 2.1.0)

Upgrade, Version, Edit

Read existing define.xml files, upgrade, version and edit

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Version Management

Version management of all items managed by the study build tool

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Audit Trail

Audit trail to record changes to items managed by the system

Configurable Settings

User management and individual configurable settings

In collaboration with

 

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The Benefits of Using the A3 Suite

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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
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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)
  • 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