1. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 1 Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +1 800 987 6007 www.clinovo.com CDISC Express® Presentation Convert clinical data to CDISC® SDTM Ale Gicqueau – November 16th 2011

2. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 2 Today’s agenda 1.About CDISC® and its benefits 2.CDISC® Express overview 3.CDISC® Express Demo 4.Benefits of CDISC® Express

3. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 3 About CDISC® The Clinical Data Interchange Standards Consortium “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.“

4. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 4 Benefits of using CDISC®  Facilitates the FDA review process  Improves efficiency for clinical data exchange  Ultimately reduces costs and speeds up time to market

5. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 5 Challenges to implement standards  Standards are still evolving  Tedious  Error prone  Time consuming

6. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 6 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

7. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 7 CDISC® Express 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

8. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 8 How to use CDISC® Express? STEP 1 Interpret CDISC standards Define your specifications STEP 2 Create your mapping file Convert your data

9. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 9 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 Download our white paper http://www.clinovo.com/resources/white-papers

10. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 10 Benefits of CDISC® Express  Open source  SAS-based for easy integration  Speed up CDISC conversion x4  Portability of Excel  User friendly web interface  Reusable macros

11. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 11 Clinovo’s CDISC® Services  Specifications writing  Training  Support  CDISC mapping  Validation  Customization Learn more about our services on www.clinovo.com/cdisc

12. © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 12 Wish to learn more? CDISC® Express Free Demo November 30 th 2011, 9:00 AM Speakers:  Kalyani Chilukuri, SAS Programmer at Clinovo  Ale Gicqueau, President & CEO at Clinovo Register for free on www.clinovo.com Contact: ale.gicqueau@clinovo.com (408)773-6250