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Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com CDISC® SDTM Conversion Made Easy with CDISC® Express Live demo of

CDISC® SDTM Conversion Made Easy with CDISC Express

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CDISC® SDTM Conversion Made Easy with CDISC Express

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Page 1: CDISC® SDTM Conversion Made Easy with CDISC Express

Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com

CDISC® SDTM Conversion Made Easy with CDISC® Express

Live demo of

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CDISC Express Demo

Clinovo’s Free Webinar Series

Clinovo hosts several webinars covering various topics:

Medidata Rave® Advanced Use

Open Source Technologies For Clinical Trials

CDISC® Conversion Made Easy with CDISC Express

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CDISC Express Demo

Today’s Speakers

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CDISC Express Demo

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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CDISC Express Demo

“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.“

Brings a unique value to the global healthcare industry

Recognized standard across all players in the industry

Works in close collaboration with the FDA

About CDISC and its mission

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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

Ultimately reduces costs and speeds up time to market

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CDISC Express Demo

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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CDISC Express Demo

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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CDISC Express Demo

• 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

A SAS-based Excel framework that automatically converts data to CDISC SDTM

Over 500 downloads

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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

Share with the SAS programmers’ community

Gather application feedback

Promote CDISC standards

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

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

Benefits

Specifications become source code

SAS-based for easy integration

Speed up CDISC conversion

Straightforward maintenance of mapping definitions

Portability of Excel

Reusable macros

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

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

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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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

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.

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