CDISC Standards are vendor-neutral and portable, they can be reused across a whole trial, across multiple platforms.
Bad Nauheim, Frankfurt, Germany (PRWEB) April 11, 2013
Formedix CEO, Mark Wheeldon has been selected to present at the upcoming CDISC Europe Interchange in Frankfurt, Germany on April 24, 2013. As part of Session 6, covering end-to-end clinical trials, Mark will be discussing “Achieving the ‘iTunes of Clinical Trials’: Storing and Sharing of Clinical Trial Content to Optimize the End-to-End Clinical Trial Process”.
Mark’s presentation will discuss how an ‘iTunes style’ metadata repository for clinical trials can be established using CDISC standardized content (CDASH and SDTM-IG) stored in a CDISC vendor neutral model (ODM/define.xml). It will also look at how clinical trial automation software enables universal design and execution of studies by leveraging this content across multiple EDC systems, multiple platforms (EDC, ePro, IVRS) and with multiple partners offering a paradigm shift in terms of flexibility (interoperability), agility & choice. Real life case studies will help explain how these are being used today.
On the topic of creating perfect libraries, Mark Wheeldon says “CDISC is ideal as you can build in quality up front. You can use tools with CDISC to see what’s actually changed. You’ll be asking questions like ‘What do I need to test and validate more extensively?’ ‘What has changed on my form?’ ‘On my dataset?’ CDISC Standards are vendor-neutral and portable, they can be reused across a whole trial across multiple platforms, i.e. EDC, ePRO and multi-vendors.”
Mark Wheeldon and Kevin Burges, Technical Business and Standards Director at Formedix, recently discussed ‘one of the most undervalued CDISC standards’ in the webinar Discover Define-XML: Practical Uses today and a Technical Deep Dive. This was the first in a series of learning webinars being held by the CDISC experts and included discussions on ‘What is Define-XML’ as well as a deeper look into the major updates with Define-XML 2.0, which was released at the end of March 2013. Formedix will be holding a number of learning webinars based around every day usage of the standards this year, so the company’s appearance at CDISC Interchange Europe will be an ideal opportunity to connect with them.
Formedix will also be exhibiting at Booth #13, so why not visit and discuss how they can help you to achieve the perfect trial? The company is also pre-booking appointments for product demonstrations, or advice on how manual, expensive and labor intensive tasks can be removed from study set-up, EDC build, validation and submission processes.
Contact Formedix to arrange a demo at Booth #13 or to receive news of upcoming events with Formedix.
For a full list of what’s taking place this year at the CDISC Interchange, visit the event website.