waynekubick.com
Thoughts on Interoperability – Reimagining Research
https://waynekubick.com/2016/02/03/thoughts-on-interoperability
Thoughts on Improving Clinical Research. February 3, 2016. February 3, 2016. Within the data standards community and especially among CDISC and HL7, the term interoperability is commonly espoused as a vision, mission and goal. For CDISC, the term refers to the ability of clinical studies to reuse data that originate as eSource from electronic health record (EHR) systems by pre-populating study CRFs through its Healthcare Link. And list of current medications. Of course interoperability is difficult.
waynekubick.com
EHR eSource: Sword of Change? – Reimagining Research
https://waynekubick.com/2016/05/31/ehr-esource-sword-of-change
Thoughts on Improving Clinical Research. EHR eSource: Sword of Change? May 31, 2016. Note: Some of this material will be published in Applied Clinical Trials, June 2016. We, in the biopharmaceutical clinical research world, are creatures of habit, doing our jobs in a consistent, repeatable process, usually driven by SOPs and systems. Change comes slowly; old habits die hard. Would we dare to try? Describes different ways to transmit eSource data (from direct capture, devices, transcription, EHRs or PRO i...
waynekubick.com
A Recipe from the SDTM Cookbook – Reimagining Research
https://waynekubick.com/2015/11/06/a-recipe-from-the-sdtm-cookbook
Thoughts on Improving Clinical Research. A Recipe from the SDTM Cookbook. November 6, 2015. November 9, 2015. In my earlier posting on SDTM as a Cookbook. I described an alternative approach for defining new domain models for use with CFAST Therapeutic Area User Guides. TAUGs). Based on an internal poll of SDS team members, there seems to be a desire to create many domain models (a predilection toward splitting, rather than the lumping approach I favor. Add any additional NSVs in the usual manner (.
waynekubick.com
Services – Reimagining Research
https://waynekubick.com/services
Thoughts on Improving Clinical Research. After leaving CDISC as CTO as of October 2015, I began offering advisory and assessment consulting services to organizations in the clinical research industry (including sponsors, CROs, government/regulators, investors and technology vendors). Now that I’ve joined HL7 as full-time CTO, I’ve had to curtail work as a consultant. Please contact me at wayne@waynekubick.com for further information. Leave a Reply Cancel reply. Enter your comment here. View @WayneKubick&...
waynekubick.com
HL7’s FHIR and BioPharma – Reimagining Research
https://waynekubick.com/2016/05/06/hl7s-fhir-and-biopharma
Thoughts on Improving Clinical Research. HL7’s FHIR and BioPharma. May 6, 2016. I’m finally beginning to get back in the swing of blogging, after a long hiatus getting ramped up at my new job as HL7 CTO. Here are a few thoughts on the HL7 FHIR standard, and how it may help reimagine clinical research in the Biopharmaceutical industry. EHR eSource: Sword of Change? Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). HL7&#...
waynekubick.com
Playing with FHIR® – Reimagining Research
https://waynekubick.com/2016/08/04/playing-with-fhir
Thoughts on Improving Clinical Research. August 4, 2016. August 17, 2016. A standard is not used because we created it. It is a standard because people use it. This familiar quote from Dr. Chuck Jaffe, CEO of HL7, could have been the motto for the inaugural FHIR Applications Roundtable. Meeting held last week at Harvard Medical School in Boston. As so many of the smiling attendees attested, this was indeed a very different kind of meeting. What was most impressive was that this roundtable only scratched ...
waynekubick.com
The “Cubs Way” to Future Submission Data Standards – Reimagining Research
https://waynekubick.com/2015/10/29/the-cubs-way-to-future-submission-data-standards
Thoughts on Improving Clinical Research. The Cubs Way to Future Submission Data Standards. October 29, 2015. October 30, 2015. Even for those who don’t follow baseball, you must have heard something about the storybook year of the out of nowhere Chicago Cubs in 2015. No, they’re not going to win the 2015 World Series, but they made the Final Four, and somehow, that didn’t feel like losing this time around. Think long term with a plan. Keep meeting current needs (but only to a point). Fill in the missing ...
assero.co.uk
Metadata and Layers
http://www.assero.co.uk/standards-for-eclinicial/metadata
Practical Metadata and Standards for Clinical Research. I have been wandering around over the last six months or so with a couple of pictures in my head that I have at last managed to commit to paper. The pictures in question try and explain why we would want to layer our metadata and through the layers link data standards and, ultimately, why the line between those standards may well begin to grey and ultimately may disappear altogether. Figure 1 - The flow of metadata. Figure 3 - The Metadata Layers.
waynekubick.com
Dear CFAST: Please Slow Down to Catch Up – Reimagining Research
https://waynekubick.com/2016/01/18/dear-cfast-please-slow-down-to-catch-up
Thoughts on Improving Clinical Research. Dear CFAST: Please Slow Down to Catch Up. January 18, 2016. January 20, 2016. A new year and many new things to think about in the greater world of research and healthcare, though there are still plenty of unfinished thoughts about CDISC to expound upon. In my last post, I tried to sum up my thoughts on SDTM. To addressing gaps in the model, especially for the CFAST Therapeutic Area User Guides (TAUGs). And today, I’d like to echo the slow food movement. Putting t...
