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Author Archives: Wayne Kubick
FDA’s Remote Monitoring Guidance: How Much is Enough?
One of the more interesting documents posted by FDA for comment is the recent draft guidance Oversight of Clinical Investigations—A Risk Based Approach to Monitoring. This document was inspired by discussions at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership involving FDA, Duke University, and many others to address certain goals of the FDA’s [...]
Posted in IT Tagged Clinical Trials Transformation Initiative, CTTI, Duke University, FDA, IT, Remote Monitoring, Wayne Kubick Leave a comment
The Great Debate: Can Pharma’s Image Save Face?
As I’ve said before, I really prefer attending DIA conferences in Europe, and not just because the food is better (which it is, even in Switzerland). Nor because the attendees are so much better dressed (Europeans have thankfully bypassed business casual). It’s not even the fact that our Euro-cousins seem so much more polite than [...]
Posted in IT Tagged Conferences, debate, DIA, EU, Europe, IT, Ken Getz, Wayne Kubick Leave a comment
IT Applications in Research: Can We All Get Along Together?
Old habits die hard. Back in the last two decades of the prior century, when commercial applications software solutions for clinical research were few, with limited functionality and often dubious quality, supported by tiny companies just trying to scrape by, many of the larger customers chose to just build their own. In those days, each [...]
Remembering the Thalidomide Tragedy at ICPE 2011
Things mostly had a familiar feel at this year’s International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Chicago. The agenda was crammed with quick-paced research paper presentations, followed by cross-ex that seemed a bit gentler than usual, and the aisles were packed with posters frequently depicting the most esoteric and nuanced research topics, [...]
Posted in IT Tagged Chicago, ICPE 2011, IT, Pharmacoepidemiology and Therapeutic Risk Management, Thalidomide, Wayne Kubick 1 Comment
FDA: Balancing Needs with Priorities
Last week’s publication “Identifying CDER’s Science and Research Needs Report” by the CDER Science Prioritization and Review Committee is the latest in a series of publications describing the FDA’s vision for the future. Much of the content builds on last September’s Strategic Priorities 2011-2015, last October’s Advancing Regulatory Science for Public Health, and even 2004’s [...]
Posted in IT Tagged CDER, Clinical Trials Repository, FDA, IT, management, risk assessment, Strategic Priorities, Wayne Kubick Leave a comment
"Can You Get Me Some Healthcare Data?"
I can’t begin to count the number of times I’ve had to answer that question, though typically the answer is always “no.” The fact is that data for testing software or exploring research problems are usually difficult to get. Clinical trials data are highly proprietary to a sponsor or investigator, and carefully controlled. Governments have [...]
EHR/EDC Interoperability: We Have Met the Enemy and He is Us
I spent much of last week’s DIA Annual Meeting in Chicago as a participant of the HIMSS Interoperability Showcase, an interactive demonstration sponsored by DIA, HIMSS, IHE, and CDISC. The showcase was a show within the show, including a small theater with live presentations on related topics, and a circle of kiosks where guided tours [...]
Posted in IT Tagged CDISC, DIA, HIMSS, HIMSS Interoperability Showcase, IHE, IT, Rebecca Kush, Wayne Kubick 1 Comment
Waking the Tiger
Beijing last week was hot, smoggy, and crowded as usual for this time of year, but the atmosphere at the DIA Annual China meeting was anything but sluggish. The meeting agenda covered a wide range of topics like other DIA conferences, though heavily weighted toward basic educational sessions on fundamental processes such as data management, [...]
Posted in CRO/Sponsor, IT, Regulatory Tagged Beijing, China, data management, DIA, DIA China, IT, Oracle, PHarmacovigilance, SFDA, TCM, Tiger, Traditional Chinese Medicine, Wayne Kubick Leave a comment
FDA Study Data Standards and Common Sense