CDISC SDTM Conversion

CDISC Express Webinar Streamline your CDISC SDTM conversion

Clinovo

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

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 The Clinical Data Interchange Standards Consortium “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.“  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 4 CDISC Express Demo Proprietary and confidential

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 between sponsors, CROs, vendors and regulatory agencies  Ultimately reduces costs and speeds up time to market

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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

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Increase in quality

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Significant cost-savings

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Challenges to implement standards  Today, CDISC conversion is 

Tedious

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Error prone

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Time consuming

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Difficult to maintain

 Standards are still evolving  ETL programmers lack CDISC expertise

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CDISC Express

CDISC Express is a free SAS® application that automatically converts clinical data into CDISC SDTM 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 WHY?  Share with the SAS programmers’ community  Gather application feedback  Promote CDISC standards  Leverage CDISC SDTM for data warehousing  Deliver training, support, customization services 12 CDISC Express Demo Proprietary and confidential

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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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 14 CDISC Express Demo Proprietary and confidential

Track record  Started at Genentech in 2007  > 3 man years of development  Over 20 studies in various therapeutic areas  >200 downloads since May 2011 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 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 15 CDISC Express Demo Proprietary and confidential

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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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 Thank you for your attention www.clinovo.com/cdisc twitter.com/clinovo

Kalyani Chilukuri SAS Programmer kalyani.chilukuri@clinovo.com (408) 773-6251

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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