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Info & Opinion
August 22, 2008
REMS Risks
FDA’s Woodcock On FDAAA
At Outcome’s Post-Approval Summit at Harvard, CDER head Janet Woodcock walked the audience through what FDAAA means.
Webinar: Tessella, United Biosource
Adaptive Designs: The Regulatory Issues
Two leading firms, Tessella and United Biosource, discuss the perception that regulators are trying to slow down the adoption of adaptive designs.
Tech Preview: Clinical Tablet
PHT Device Aimed At Sites
The patient-reported outcome company moves its software to a Samsung device with a new form factor and operating system.
Profile: Phlexglobal
Mastering The Trial Master File
More global locations and outsourcing can make for a messy process to generate a trial master file (TMF). Phlexglobal bundles services and software to help.
Sponsors in denial?
2008 eCTD Train Wreck?
Warren Perry of Qumas warns that some of the industry will be unprepared for the FDA insisting on its long-planned transition to the eCTD.
We’re digesting our DIA notes from this year’s annual meeting in Atlanta. Still. One of memorable presentations was from Susan Flynn, chief quality officer at Clinsys Clinical Research, a contract research organization. The company has 300 clinical research professionals; its headquarters are in New Jersey. Flynn speaks with the benefit… more...
Does Microsoft matter in clinical trials? Is it staring numbly at the start of an era of enterprise-worthy, web-based tools from Google? Or does Microsoft have unique hardware, application and networking tools that make it a more or less indispensable part of the technological infrastructure of the modern clinical trial?… more...
Despite the fact that some European biotechs have been touting microdosing as the next big thing, sponsors in the U.S. are still not rushing out in great numbers to give the extremely low-dose trials a whirl. In fact, says the FDA‘s David Jacobson-Kram, associate director of pharmacology and toxicology in… more...
Mission3, an Arizona-based provider of pharmaceutical project, document, and submission management software, announced that it continues its drive for good informatics practices through its partnership with LSIT Global Institute. LSIT has published an article by Dirk Karsten Beth, president of Mission3. Writes Beth: “The eCTD submission [electronic common technical document]… more...
Does the digital world have warts? Yes. They’re called PDFs. The venerable Adobe format is a digital scourge. The PDF is not truly searchable. It’s not version controlled. It’s not auditable. PDFs are big, dumb, proliferating images. There is only one safe, FDA-approved treatment for PDFs: XML. XML also treats… more...
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 clinical trial technological concerns that have taken pains to ensure… more...
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. It’s an interesting acquisition for Octagon, with potentially far-reaching ramifications… more...
Maybe it’s just a new season. The end of a Boston winter, even a mild winter, is a fine thing. A still better thing is a sensible, forward-looking statement by the FDA in the Federal Register. Earlier this month, the FDA announced a pilot project to help it figure out… more...
The recent Drug Information Association (DIA) conference on data management had the usual number of FDA presentations that put many commercial conferences to shame. And one of the most interesting FDA presentations was from Armando Oliva, deputy director of bioinformatics in the office of Critical Path programs. That’s inside the… more...
The FDA is proposing a massive cut to its Office of Women’s Health (OWH), and Ruth Merkatz—director of the office from its inception to 1996—is flaming mad. “This is very unfortunate; we just hate to see the books being balanced on the backs of women’s health,” said Merkatz, adding that… more...
