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The mission of CDISC is to develop and support global, platform-independent data standards to improve medical research. As a CDISC Gold Member, Clinovo has been continuously supporting the adoption of CDISC standards to accelerate clinical trials.This webinar benefits industry professionals looking for efficient ways to convert clinical data to global standards. Discover CDISC® Express, our free innovative CDISC SDTM mapping tool.
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Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com
CDISC Express Webinar Streamline your CDISC SDTM conversion
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CDISC Express Demo
Today’s Speakers
Kalyani Chilukuri
SAS Programmer
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Today’s Agenda
About CDISC and its mission
How can life science companies take advantage of CDISC data standards
Overview and benefits of CDISC Express
Demo of CDISC Express
Q&A session
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CDISC Express Demo
CDISC
“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.“
The Clinical Data Interchange Standards Consortium
CDISC brings a unique value to the global healthcare industry
CDISC is a recognized standard across all players in the industry
Works in close collaboration with the FDA
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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 between sponsors, CROs, vendors and regulatory agencies
Ultimately reduces costs and speeds up time to market
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CDISC Express Demo
Why implement CDISC standards?
CDISC as data middle tier
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
Today, CDISC conversion is Tedious Error prone Time consuming Difficult to maintain
Standards are still evolving
ETL programmers lack CDISC expertise
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CDISC Express Demo
CDISC Express
CDISC Express is a free SAS® application that automatically converts clinical data into CDISC SDTM
• 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
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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
WHY?
Share with the SAS programmers’ community
Gather application feedback
Promote CDISC standards
Leverage CDISC SDTM for data warehousing
Deliver training, support, customization services
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
Benefits
Specifications become source code
SAS-based for easy integration
Speed up CDISC conversion
Straightforward maintenance of mapping definitions
Portability of Excel
User friendly web interface
Reusable macros
Online support system
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CDISC Express Demo
Track record
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 on average. Stetson Line, Senior Manager of Clinical Programming, Genentech
Started at Genentech in 2007
> 3 man years of development
Over 20 studies in various therapeutic areas
>200 downloads since May 2011
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
Your response has been very helpful. I've successfully created my first domain, DM! Great tool. Sheila Dayog, Statistical Programmer Analyst, Genentech
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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
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
Thank you for your attention
www.clinovo.com/cdisc
twitter.com/clinovo
Kalyani Chilukuri
SAS Programmer
(408) 773-6251
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.
