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CDISC® SDTM Conversion Made Easy with CDISC Express
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Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com
CDISC® SDTM Conversion Made Easy with CDISC® Express
Live demo of
Proprietary and confidential
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CDISC Express Demo
Clinovo’s Free Webinar Series
Clinovo hosts several webinars covering various topics:
Medidata Rave® Advanced Use
Open Source Technologies For Clinical Trials
CDISC® Conversion Made Easy with CDISC Express
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CDISC Express Demo
Today’s Speakers
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CDISC Express Demo
Today’s Agenda
About CDISC and its mission
Benefits of CDISC data standards
Overview and benefits of CDISC Express
Demo of CDISC Express
Q&A session
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CDISC Express Demo
“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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CDISC Express Demo
Is your organization taking advantage of the CDISC data standards?
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CDISC Express Demo
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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CDISC Express Demo
Why implement CDISC standards?
Good investment if more than 3 studies
End-to-end usage, from start-up stage to submission
SAS code re-usability
Listings, reports, patient profile, Edit Checks, ADS
Increase in quality
Significant cost-savings
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CDISC Express Demo
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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CDISC Express Demo
• Sharing with the community
• Promoting CDISC standards FREE
• Ubiquity of SAS for clinical trials
• Easy-integration SAS
• Easy-to-use
• Self-contained, platform independent EXCEL
A SAS-based Excel framework that automatically converts data to CDISC SDTM
Over 500 downloads
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CDISC Express Demo
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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CDISC Express Demo
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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CDISC Express Demo
Features
Excel based mapping definitions
Global SDTM definitions
Extensible function library
Lab standard units and toxicity levels
Generic SDTM validation tool
Controlled terminology
Define.XML
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CDISC Express Demo
DEMO Download CDISC Express
www.clinovo.com/cdisc/download
Watch a demo
http://www.clinovo.com/cdisc_documentation/videotutorial.htm
Report a technical issue or send us your feedback
cdiscsupport.clinovo.com
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CDISC Express Demo
Benefits
Specifications become source code
SAS-based for easy integration
Speed up CDISC conversion
Straightforward maintenance of mapping definitions
Portability of Excel
Reusable macros
CDISC Express is the only CDISC SDTM conversion tool to map all your clinical data in just one click. It keeps the trivial work away from programmers’ daily life and allows us to be more efficient and creative in our work.
Jiangtang Hu , SAS Programmer, Sanofi-Aventis
It took about 3 months to develop CDISC mappings in an alternate application. A Clinovo programmer was able to achieve similar results in under 2 weeks.
Stetson Line, Sr. Manager of Clinical Programming, Genentech
I've successfully created my first domain, DM! Great tool. Sheila Dayog, Statistical Programmer Analyst, Genentech
CDISC Express is the best tool to turn mapping SDTM easy, straightforward, with high reliability and accuracy. . It saves SAS programmers’ time while increases data quality.
Chunmao Wang, Clinical Statistical Programmer
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CDISC Express Demo
Clinovo CDISC services
Specifications writing
Training
Monthly support
CDISC mapping
Validation
Customization
Learn more about our services on www.clinovo.com/cdisc
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CDISC Express Demo
Q&A
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CDISC Express Demo
Contact us
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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