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July 24, 2008
CDASH Webinar Tomorrow
Carbonic e-Case Report Forms
Rhonda Facile of CDISC talks about the CDASH effort to standardize case report forms. The first public release is due soon.
When Speed Means Slow
Rozwell on Data Standards (Podcast #1)
Gartner distinguished analyst Carol Rozwell talks about drug safety, contract research organizations, data mining and other topics related to CDISC standards.
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The good news is: cloning works. The catch? You have to rethink your most cherished and convoluted case report forms (CRF). Barely two years ago, CDISC president Becky Kush, the well-travelled and uber-diplomatic Henry Kissinger of the clinical trial realm,…
According to Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), pharmaceutical companies should be developing the capabilities to submit common technical document (CTD) applications electronically, or should utilize eCTD applications. Although submitting both new drug applications (NDAs)…
The Clinical Data Interchange Standards Consortium (CDISC) does not want for savvy high-energy volunteers or high-profile member organizations. For evidence of that, just hang out at CDISC’s user meeting, which is coming up in October. There’s just one problem. Using…
GlaxoSmithKline took a bullet from the anti-industry New England Journal of Medicine, which did a meta-analysis of data about the GSK diabetes drug Avandia. The Cleveland Clinic’s Steve Nissen calculates Avandia to raise the odds of cardiovascular-related death by 64…
The honor system didn’t work, it seems. Last week, the Clinical Data Interchange Standards Organization (CDISC) officially certified two vendors (as far as we can tell) as compliant with the operational data model (ODM). ClinPhone and XClinical are both European…
Clinipace, a clinical research software company focusing on clinical trials and patient registries, has announced the launch of its Empowered Partner Program (EPP). In response to the industry’s need for highly configurable clinical software, Clinipace is offering small and medium-sized…
We’re wearing our flame-retardant pants today, just in case anyone sends an email our way. Wayne, Pennsylvania’s Octagon Research recently purchased Ninaza, a financially troubled electronic data capture (EDC) company in California. Ninaza had specialized in registries and post-approval trials.…
There are great hopes but more than a little uncertainty around whether the pharmaceutical industry will ever have the technical means or the political latitude to mine troves of data in electronic health records. Some people point to pilot projects…
