INVESTOR NEWSLETTER ISSUE N°3


FIRST QUARTER 2016FALL 2009


(anything from the FDA Guidance to the site processes to the Sponsor procedures or the technology). We want to approach this deliberately and explicitly - so we'll break the problem up into digestible parts, or questions to be answered, and we'll seek volunteers to help us focus attention on those questions and generate answers to them. The questions to be answered will encompass the full data path to success, so there will be technological questions, but also data provenance questions, policy questions, scalability questions. We'll try to eat the elephant one bite at a time, but with a lot of hungry participants working together.


After the meeting we'll have an agreed charter and our list of questions and groups that have volunteered to get this done. And with any luck, in short order we'll have not only successful demonstration projects to share, but also a coherent and realistic approach to realizing interoperability for regulated research that anyone can pick up and follow along, to increase their understanding and chances of success. Almost a year ago, J. Halamka blogged about interoperability and how to really get it done: "If we stay above the fray, work on interoperability one practice and one institution at a time, and toil diligently...we will create a learning healthcare system that is better with each passing year.”


(http://geekdoctor.blogspot.com/2015/05/interoperability-and-trough-of.html; Wed 27 May, 2015 *Interoperability and the Trough of Disillusionment*)


We hope this time next year we can say the same of this effort. For more information and updates on Healthcare Link, please visit the CDISC website here.


CDISC Hosts First Fundraiser to Support PTS & Mental Health Research Andrea Vadakin, Director, Communications & Public Relations


Earlier this month, I had the opportunity to join my colleagues in Austin for our first fundraiser, held on 03 March, which this year celebrated our partnership with One Mind and the recent release of the CDISC standard for Traumatic Brain Injury, and supported efforts to develop further clinical research standards for Post-Traumatic Stress and other


mental health Depressive Disorder.


While I have been to a great number of CDISC Interchanges, I have never had the chance to participate in an awareness event like this one, and I must admit, it was incredibly inspiring to hear from leaders in Austin area, and from advocates in mental health, the benefits that eventually reach patients through use of the CDISC standards. The crowd included experts in the field of mental health research, veterans, patient advocates, musicians and supporters.


The crowd mingling at the beginning of the event.


Distinguished speakers included the Dean of the new Dell Medical School at the University of Texas - Austin, Dr. Clay Johnston, who, in addition to his new role at UT, is also a recognized neurologist, specializing in stroke care and research. In his opening remarks, Dr. Johnston expressed his appreciation for the work that CDISC is doing, and his anticipation of our continued collaboration.


CDISC CDIS CDI C WEBSIT LINK WEBSITE LINK 6 liin lliin liin lliin issues, such as Major


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