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CDISC速 SDTM Conversion Made Easy with CDISC速 Express Wednesday, February 29th 2012

Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +1 800 987 6007 www.clinovo.com


Clinovo’s Free Webinar Series Clinovo hosts several webinars covering various topics:

Medidata Rave® CDISC® Data Conversion Open Source For Clinical Trials Adaptive Clinical Trials

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Today’s Speakers

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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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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?  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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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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A SAS-based Excel framework that automatically converts data to CDISC SDTM Over 500 downloads

FREE

• Sharing with the community • Promoting CDISC standards

SAS

• Ubiquity of SAS for clinical trials • Easy-integration

EXCEL

• Easy-to-use • Self-contained, platform independent

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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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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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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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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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Benefits Specifications become source code SAS-based for easy integration Speed up CDISC conversion

Straightforward maintenance of mapping definitions Portability of Excel Reusable macros 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

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

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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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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Q&A

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Contact us Ale Gicqueau, President & CEO ale.gicqueau@clinovo.com

@clinovo

Follow us! www.clinovo.com

CDISC速 is a registered trademark of CDISC, Inc. 速 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. 速 indicates USA registration. Other brand and product names are trademarks of their respective companies.

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Thank You for your Attention ! Visit our website to see our webinar archives: www.clinovo.com

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CDISC® Express Webinar, February 29th, 2012