Paris, France – 28 August 2009 – KIKA Clinical Solutions, the leading provider of advanced EDC solutions for clinical trials, announced that Simon Hawken, KIKA’s Director of Business Development in Europe and a member of the ESUG Committee, will chair a teleconference entitled “HL7 and the Link to CDISC” for the CDISC English Speaking User Group (ESUG).
Date: 17 September 2009
UK Time: 14.00 to 15.30 p.m.
Europe Time: 15.00 to 16.30 p.m.
US Time: 09.00 to 10.30 a.m.
Clinical data are not flat and cannot be exchanged using flat two-dimensional files without significant loss of meaning. The FDA is transitioning to a “round view of the world” of clinical research and the CDISC-HL7 standards will help them get there. SDTM is here to stay but will transition from a standard submission format to a standard view of the data in support of simple analysis. Session participants will learn more about:
- How the CDISC-HL7 standard will benefit regulatory review of clinical research
- How will it impact on the SDTM standard?
- What is the CDISC-HL7 standard?
- Why do we need the CDISC-HL7 exchange standard?
- How is the standard being developed?
- When will the standard be available?
- When will the FDA implement it?
More information is available at www.esug.org.uk. Registration is required.
Email registrations@esug.org.uk to sign up for this event.
KIKA Clinical Solutions
KIKA helps the world's most innovative biopharmaceutical and medical device organizations bring much-needed medical solutions to the market faster. KIKA’s Clinical Asset Management platform provides unmatched flexibility and customization with advanced EDC including images and online adjudication. KIKA is the developer of Veracity, the Web-based software platform that offers pharmaceutical and medical device companies the industry’s most reliable, flexible EDC solution. Veracity is customized to meet study needs precisely – from an intuitive user interface that makes EDC truly user-friendly, to its Clinical Data Management software. With CDISC ODM architecture at its core, Veracity is the leading-edge of internal data organization and storage technology. Through its Web services architecture, Veracity connects and communicates with other software and systems. For more information, visit www.kikaclinicalsolutions.com.
KIKA and Veracity are trademarks of the KIKA group of companies.
Media contact: Brenda Nashawaty, bnashawaty@kikamedical.com, 617-688-3253