Streamlined CDISC速 Conversion and Reporting Live demo of
Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +1 800 987 6007 www.clinovo.com
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Today’s Speakers
2 Streamlined CDISC Conversion and Reporting Proprietary of Clinovo
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
3 Streamlined CDISC Conversion and Reporting Proprietary of Clinovo
Efficient Reporting in compliant standards
Advanced real-time reporting in compliant standards is needed from:
Executives
Monitors
CRAs
Data Manager
Clinicians
Electronic Data Capture (Rave, Inform, OCL, ClinCapture, etc…)
CDISC Standards Native SDTM adaptor included
Value of integration:
Compliance + Real-Time + Cost-savings
4 Streamlined CDISC Conversion and Reporting Proprietary of Clinovo
About CDISC and its mission “ The mission of CDISC is to develop and support global, platformindependent 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
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Is your organization taking advantage of the CDISC data standards?
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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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Why implement CDISC standards? End-to-end usage: from start-up stage to submission SAS code re-usability
Increase in quality Significant cost-savings
8 Streamlined CDISC Conversion and Reporting Proprietary of Clinovo
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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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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Open Source Open source SAS code
Extensible framework Custom macros Share with the SAS programmers’ community Gather application feedback Promote CDISC standards
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How to use CDISC® Express?
STEP 1
STEP 2
• Interpret CDISC standards • Define your specifications
• Create your mapping file • Convert your data
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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 contact@clinovo.com
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What is Comprehend Clinical™?
Comprehend Clinical™ is a next-generation clinical visualization and analytics tool that works through a standard web browser.
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Comprehend Clinical Benefits Web-based Visualization and analytics with powerful dashboards Intelligent reporting Truly multi-datasource without moving the data Reactivity Native SDTM adaptor
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Features Overview Dashboard interface Intelligent drill down Ad-hoc reporting Filters and subsets Reports Real-time alerting
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Compliance 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
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System Security 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
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Your Most Important Metrics Site Information Safety and Efficacy Supply and Resupply Patient Management
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DEMO
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Conclusion: Integration Benefits
Data Capture
EDC / CDMS / CTMS / SAFETY / IVRS
CDISC Conversion
Reporting
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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.
22 Streamlined CDISC Conversion and Reporting Proprietary of Clinovo