advanced metadata management, now with data! · 2019. 2. 21. · an advanced, fully integrated...
TRANSCRIPT
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Advanced Metadata Management, Now With Data!
FORMEDIX ON
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2000: Formedix founded to improve how trials are run
2003: CDISC-based study design (CRFs)
2008: CDISC-based dataset design
2014: On demand services
2017: Centralized metadata governance platform
Great for building studies, managing standards, and generating submission deliverables
Impact analysis and governance
Dataset conversions are manual
2019: Data integrations and automated SDTM conversions
BACKGROUND
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An advanced, fully integrated online platform to facilitate clinical trials. This includes:
• A central repository for storing and managing all your metadata, across the end-to-end life cycle of your studies
• Management of organizational standards, helping you increase data quality and decrease downstream costs
FORMEDIX ON
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Your whole team can now access all your studies and
organizational standards in one place, on the web
CENTRAL REPOSITORY
YOUR
STANDARDSYOUR
STUDIES
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All your metadata is managed in one place
This greatly simplifies the management of studies and standards
END-TO-END
FORMS DATASETS TERMINOLOGIES FILES
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• Show menu, including Studies and Standards
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• Open a Study, show different asset types listed
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• Show details of a Form
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• Show details of a Form
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• Show details of a Dataset
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• Define and maintain organizational standards that can be used to build studies, increase data quality and reduce design time
- These can be managed by your standards team and made available to your study teams for building studies
• Standardizing variations of assets for specific therapeutic areas further increases the efficiency of your study design process
ORGANIZATIONAL STANDARDS
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• Your organizational standards can contain assets from any part of the clinical lifecycle
- This allows standards to be managed end-to-endE.g. an "AE" standard may contain AE-related CRFs, any related datasets and mappings, and instructions on how to use the standard
• Ensuring all assets in your standard are consistent with each other, makes building studies a breeze
- e.g. Your datasets match your CRF and are mapped to it
ORGANIZATIONAL STANDARDS
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Compare a study to your standards, or other studies, or previous versions
VIEWING DIFFERENCES
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• Comparison to a previous version
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Impact analysis helps you make informed choices
IMPACT ANALYSIS
AE Form Change
Study 1
Study 2
Study 3
Study 4
Study 5
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Define your own governance processes and approval gates
Use change requests to manage updates in a controlled and consistent manner
CONFIGURABLE GOVERNANCE
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CONFIGURABLE METADATA LIFECYCLE
Define your own metadata lifecycle
E.g. Studies may have the following states:
Draft, In review, Production, Rejected, Not in use
Standards may have:
Draft, In review, Production, Rejected, Not in use, Superseded
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VISUALIZATIONS FOR ALL
Your teams can access advanced visualizations of your assetsAvailable anytime, anywhere, on the web
eCRF
PREVIEWS
EDIT CHECK
SPECIFICATIONS
ANNOTATED
CRFs
SDTM MAPPING
SPECIFICATIONS
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See exactly how your forms will look in your chosen EDC
No need to build the EDC system first
VISUALIZE eCRFs
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• Unique integrations with the top EDC systems
• Pick your EDC system with the click of a button
• Design your entire study in Formedix On
• Automatically build the EDC database
EDC INTEGRATIONS
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• Visualizations list for a Form
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• Form visualization for Oracle
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• Form visualization for Rave
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• Visualizations list for an Asset Group
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• Show Visit Schedule for an EDC
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• Show Dataset prediction visualization for Rave
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• Show Define visualization for Datasets
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• Show mapping or traceability visualization for Mappings
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• Define mappings from your source data to SDTM
• Generate SDTM datasets from your EDC and other source data
• Run dataset conversions throughout your study
AUTOMATED SDTM DATASET GENERATION
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2019 brings data integration with 3rd party systems, allowing an automated end-to-end data conversion process
This includes:
- Linking your studies to your EDC system
- Scheduled data import into Formedix On
- Automated conversion of data to SDTM
- Automated push of SDTM data into downstream systems
AUTOMATED SDTM DATASET GENERATION
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ON DEMAND DIGITAL SERVICES
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• Show ODS page
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• Role-based access to standards and studies
- Standards can be available to all, or locked down to specific teams
- Studies can be open to all or restricted to a smaller study team
• Individual teams can have different access
- Data Managers may be able to edit forms and view datasets
- Biostatisticians may be able to view forms and edit datasets and mappings
• Single Sign On (SSO)
- User provisioning and access rights can be controlled through your organization's identity management platform
ACCESS CONTROL
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• Sponsors
• CROs
• Independent contractors
DESIGNED FOR DIFFERENT TYPES OF CUSTOMERS
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Support for the core CDISC models
CDISC STANDARDS
ODM Define-XML Dataset-XML
SDTM Analysis Results Metadata SEND
ADaM NCI CT
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As you can see, we’ve been hard at work enhancing Formedix On to enable a fully automated SDTM generation process
Metadata repositories are all the rage, but they often haven’t delivered
We’re focused on delivering the key benefits of the MDR vision in a simple, affordable, user friendly format with deep EDC integration
formedix.com
SUMMARY