Medidata Solutions & Cognizant invite Pharma Labs and Biotechs to an event about CDISC standard on June 13.

1. INVITATION
Thursday 13 June from 8:30 am to 2:00 pm at the Cercle Suédois, 242 rue de Rivoli, Paris-FR
CDISC Standards from Study Design to Analysis
An open discussion on best practices to execute on CDISC in order to transform clinical data efficiency around
three scenarios: Legacy Data, Data Hub/Repository and Real Time Data.
With the participation of Dr. Pierre-Yves Lastic, Chair-Elect, CDISC Board of Directors, William Sauret, Clinical
Data Manager at Nestlé and Pharmaceutical Groups representatives.
REGISTER TODAY
Contact us:
blebourgeois@mdsol.com;
Anne.Taudin@cognizant.com;
For years, CDISC SDTM has been the preferred format for submissions to the US Food and Drug Administration
(FDA). But getting to SDTM is made even simpler by complying with other CDISC standards across the clinical
lifecycle.
Today’s life science organizations are looking to:
 Transform data more efficiently into SDTM format;
 Capitalize on CDISC standards adoption prior to submission;
 Optimize their clinical development lifecycle;
 Improve collaboration with their vendor ecosystem; and
 Increase their flexibility to adapt to regulatory guidance.
However, retroactively standardizing legacy data can be a very complex task. And standardization projects
have the best chance for success if approached in a holistic way. Research shows that implementing CDISC-
based global standards can reduce the effort required for sub-tasks in the study lifecycle by up to to 76 %, so
it’s no wonder that pharmaceutical companies are looking to adopt data standards throughout the clinical
process.
In this seminar, we will present practical insights on how to:
 Comprehend the latest regulatory changes on data standards;
 Prepare for SDTM no matter the situation :
- Legacy Data
- Clinical Data Repository (CDR)
- In real time data resulting from test process
 Identify how your clinical process can benefit from adopting other CDISC standards.
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*Profiles invited > Members of pharmaceutical / biotech / medical supplies companies, and particularly
Heads of Data Management, R&D IT Directors, Statisticians and Programmeers who are constantly confronted
to the clinical data standards challenges. CROs, consultants and Services providers aren’t accepted.
Topics > Solutions built and based on worldwide best practices, state of the art tools demoed, CDISC point of
view with CDISC European Leader presence as guest, Insights from your peers and our experts during a round
table and Networking opportunities during our breaks.
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2. AGENDA
8:30 Welcome coffee
9:00 Introduction
Medidata & Cognizant
9:30 CDISC Implementation Begins with Your Protocol
Medidata: Richard Young (Presentation in English)
10:00 Legacy Data & Data Hub (CDR) SDTM Standard Transformation
Cognizant: Olavi Grundics (incl. solution CDISC Gateway) (Presentation in English)
10:30 Real Time Data SDTM Standard Export Strategy
Cognizant & Medidata
11:00 Coffee Break and Demos
11:45 Customer Story: Use Cases in Practice (scenarii)
Cognizant
12:15 Round table: Five Questions on CDISC Pain Points and Practical Solutions
Guest speakers: Pierre-Yves Lastic, Chair-Elect, CDISC Board of Directors
and William Sauret, Clinical Data Manager, Nestlé
13:15 Lunch
14:00 Adjourn
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Medidata Solutions and Cognizant have been successfully partnering in the past 5 years to deliver innovative
cutting edge and customized solutions for pharmaceutical companies to adapt global CDISC standards and
ultimately reach their drug development goals.
COGNIZANT: A global leading provider of consulting and IT-Business services working with a pool of over
10,000 pharmaceutical industry specialists who work for 27 of the top 30 biggest pharmaceutical companies
worldwide. www.cognizant.com
MEDIDATA SOLUTIONS: a leading global provider of cloud-based clinical development solutions that enhance
the efficiency of customers' clinical trials. www.mdsol.com
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Register Today
By contacting either Bertrand Le Bourgeois at +44 (0) 2086006430 or blebourgeois@mdsol.com, or
Anne Taudin at +33 (0)1 70 36 56 67 or anne.taudin@cognizant.com.
If you cannot attend, and would like to receive the speakers’ presentations and/or learn more about
Cognizant and Medidata Solutions, please contact them also.
Warning: this free event privileges the exchanges with a small committee being gathered. Thus, registrations
confirmations will be provided pending within participations limits. Thanks for your understanding.