CDISC® SDTM Conversion Made Easy with CDISC Express

CDISC速 SDTM Conversion Made Easy with CDISC速 Express Live demo of

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® Advanced Use  Open Source Technologies For Clinical Trials  CDISC® Conversion Made Easy with CDISC Express

2 CDISC Express Demo Proprietary and confidential

Today’s Speakers

3 CDISC Express Demo Proprietary and confidential

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

4 CDISC Express Demo Proprietary and confidential

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

5 CDISC Express Demo Proprietary and confidential

Is your organization taking advantage of the CDISC data standards?

6 CDISC Express Demo Proprietary and confidential

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

7 CDISC Express Demo Proprietary and confidential

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

8 CDISC Express Demo Proprietary and confidential

Challenges to implement standards

Tedious & Error prone Time consuming Difficult to maintain Standards are still evolving ETL programmers lack CDISC expertise

9 CDISC Express Demo Proprietary and confidential

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

10 CDISC Express Demo Proprietary and confidential

How to use CDISC® Express?

STEP 1

STEP 2

• Interpret CDISC standards • Define your specifications

• Create your mapping file • Convert your data

11 CDISC Express Demo Proprietary and confidential

Open Source  Open source SAS code

 Extensible framework  Custom macros  Share with the SAS programmers’ community  Gather application feedback  Promote CDISC standards

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

13 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

14 CDISC Express Demo Proprietary and confidential

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

15 CDISC Express Demo Proprietary and confidential

Clinovo CDISC services  Specifications writing  Training  Monthly support  CDISC mapping  Validation  Customization

Learn more about our services on www.clinovo.com/cdisc

16 CDISC Express Demo Proprietary and confidential

Q&A

17 CDISC Express Demo Proprietary and confidential

Contact us Follow us!

Clinovo's news & invitations • Register for free to webinars and events • Be the first to read our publications • Learn more about our services and systems

@clinovo

Subscribe on clinovo.com/news

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.

18 CDISC Express Demo Proprietary and confidential