© 2011 clinovo. all rights reserved. the contents of this document are confidential and proprietary...

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© 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 [email protected] +1 800 987 6007 www.clinovo.com CDISC Express® Presentation Convert clinical data to CDISC® SDTM e Gicqueau – November 16th 2011

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

1

Clinovo1208 E. Arques Avenue, Suite 114Sunnyvale, CA [email protected]+1 800 987 6007 www.clinovo.com

CDISC Express® PresentationConvert clinical data to CDISC® SDTMAle Gicqueau – November 16th 2011

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

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Today’s agenda

1. About CDISC® and its benefits

2. CDISC® Express overview

3. CDISC® Express Demo

4. Benefits of CDISC® Express

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

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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.“

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

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Benefits of using CDISC®

Facilitates the FDA review process Improves efficiency for clinical data exchange Ultimately reduces costs and speeds up time to market

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

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Challenges to implement standards

Standards are still evolving

Tedious

Error prone

Time consuming

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

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CDISC® Express is a free SAS® application that automatically converts clinical data into CDISC® SDTM

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

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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

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

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How to use CDISC® Express?

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

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DEMODownload 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 feedbackcdiscsupport.clinovo.com

Download our white paperhttp://www.clinovo.com/resources/white-papers

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

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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

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

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Wish to learn more?

CDISC® Express Free Demo November 30th 2011, 9:00 AM

Speakers: Kalyani Chilukuri, SAS Programmer at Clinovo Ale Gicqueau, President & CEO at Clinovo

Register for free onwww.clinovo.com

Contact:[email protected]

(408)773-6250