streamlined cdisc conversion and reporting
DESCRIPTION
Streamlined CDISC Conversion and Reporting for Clinical TrialsTRANSCRIPT
Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com
Streamlined CDISC® Conversion and Reporting
Live demo of &
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Streamlined CDISC Conversion and Reporting
Today’s Speakers
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Streamlined CDISC Conversion and Reporting
Today’s Agenda
Efficient Reporting in compliant standards
Benefits of using CDISC® data standards
Overview and benefits of CDISC Express and Comprehend Clinical
Demo of CDISC® Express, Clinovo's internal SAS-based mapping system
Demo of Comprehend Clinical, next generation clinical data reporting tool
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Streamlined CDISC Conversion and Reporting
Efficient Reporting in compliant standards
Advanced real-time reporting in compliant standards is needed from:
Executives
Monitors
CRAs
Data Manager
Clinicians
Value of integration:
Compliance + Real-Time + Cost-savings
CDISC Standards
Native SDTM adaptor included
Electronic Data Capture (Rave, Inform, OCL, ClinCapture, etc…)
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Streamlined CDISC Conversion and Reporting
“The mission of CDISC is to develop and support global, platform- independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.“
Brings a unique value to the global healthcare industry
Recognized standard across all players in the industry
Works in close collaboration with the FDA
About CDISC and its mission
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Streamlined CDISC Conversion and Reporting
Is your organization taking advantage of the CDISC data standards?
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Streamlined CDISC Conversion and Reporting
Benefits of using CDISC standards
Facilitates the FDA review process
Improves efficiency for clinical data exchange
Ultimately reduces costs and speeds up time to market
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Streamlined CDISC Conversion and Reporting
Why implement CDISC standards?
End-to-end usage: from start-up stage to submission
SAS code re-usability
Increase in quality
Significant cost-savings
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Streamlined CDISC Conversion and Reporting
Challenges to implement standards
Tedious & Error prone
Time consuming
Difficult to maintain
Standards are still evolving
ETL programmers lack CDISC expertise
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Streamlined CDISC Conversion and Reporting
Features :
Create and customize mapping files
Generate the SDTM domains
Generate the Define.xml
Validate the SDTM domains
Benefits :
SAS powerful capabilities
Highly extensible
Speed of data conversion x4
Code re-usability
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Streamlined CDISC Conversion and Reporting
Open source SAS code
Extensible framework
Custom macros
Share with the SAS programmers’ community
Gather application feedback
Promote CDISC standards
Open Source
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Streamlined CDISC Conversion and Reporting
How to use CDISC® Express?
STEP 1
• Interpret CDISC standards
• Define your specifications
STEP 2
• Create your mapping file
• Convert your data
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Streamlined CDISC Conversion and Reporting
DEMO Download CDISC Express
www.clinovo.com/cdisc/download
Watch demos clinovo.com/cdisc_documentation/videotutorial.htm clinovo.com/eclinical-systems/comprehend-clinical
Report a technical issue or send us your feedback cdiscsupport.clinovo.com or [email protected]
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Streamlined CDISC Conversion and Reporting
Comprehend Clinical™ is a next-generation clinical visualization and analytics tool that works through a standard web browser.
What is Comprehend Clinical™?
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Streamlined CDISC Conversion and Reporting
Web-based
Visualization and analytics with powerful dashboards
Intelligent reporting
Truly multi-datasource without moving the data
Reactivity
Native SDTM adaptor
Comprehend Clinical Benefits
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Streamlined CDISC Conversion and Reporting
Features Overview
Dashboard interface
Intelligent drill down
Ad-hoc reporting
Filters and subsets
Reports
Real-time alerting
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Streamlined CDISC Conversion and Reporting
Good Documentation Practices (GDPs)
21 CFR Part 11
Detailed data audit trail
Tested and validated systems for the specified requirements
Disaster recovery procedures and backup facility
Record retention and protection procedures
Restricted user access to the system
Compliance
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Streamlined CDISC Conversion and Reporting
Administrators Control
System access
Manage users by roles
Control who sees and does what
Enhance Custom Reports
Drill-down / filters
Add / remove fields
Graphs / charts
System Security
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Streamlined CDISC Conversion and Reporting
Site Information
Safety and Efficacy
Supply and Resupply
Patient Management
Your Most Important Metrics
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Streamlined CDISC Conversion and Reporting
DEMO
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Streamlined CDISC Conversion and Reporting
Reporting
Data Capture EDC / CDMS / CTMS / SAFETY / IVRS
CDISC Conversion
Conclusion: Integration Benefits
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Streamlined CDISC Conversion and Reporting
Keep in touch!
CDISC® is a registered trademark of CDISC, Inc. ® indicates USA registration.
SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS
Institute Inc. in the USA and other countries. ® indicates USA registration.
Other brand and product names are trademarks of their respective companies.
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