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.
In a new survey of 598 investigator site personnel, there is an unhappy snapshot of the most oppressed and disgruntled segment of the clinical trial workforce. According to the survey, clinical sites are aware of using the Internet to collaborate and manage industry research. But investigators and their staff feel the sponsor community is still too prone to use paper-centric processes that the colonial-era John Hancock would have understood. As an electronic document management company, IntraLinks (which conducted the survey with CenterWatchPaper…more...
The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials. Should the agency implement and finalize…more...
Late last year, the FDA released a draft guidance on electronic source, or "e-source." It's not as exciting as rebelling Libyans or Charlie Sheen's rants, to be sure. But the ramifications…more...
Whenever we publish anything about imaging core labs, it seems, a good Samaritan rushes forward to point out all of the room for improvement in our previous articles. It's moderately discouraging…more...
What are appropriate turnaround times as images pass through the different stages of a clinical trial? Is the pharmaceutical industry applying outmoded thinking? Here's the context for such questions. A few weeks back, we ran an article on benchmarks in imaging. In brief, Perceptive Informatics, a division of Parexel, had adopted some standards in consultation with a…more...
Honestly? The word has tormented us. We are talking about “eclinical.” The once-technical term is now routinely being referenced on calls with Wall Street analysts. Google has zillions of links to it. We finally decided to wrestle with it in our own way. To facilitate a serious journalistic contemplation of “eclinical,” we purchased an 80 oz. (5…more...
For years, we’ve been mocking it. There have been unkind remarks. Words like antique, prehistoric, pre-computer, Elizabethan. “Dickensian” is our favorite. We’re talking about ... paper. Then we found ourselves on the phone with a gentleman who makes a good argument for paper. “We provide immediate information for the sponsor or CRO. But we keep it very…more...
Should the life sciences be in a self-congratulatory mood about moving away from paper and toward electronic data capture (EDC)? Nope. For Ron Waife, president of Waife & Associates, it may be premature to ask John Williams to compose a symphony to celebrate the shift. Waife is simply not sure EDC’s full potential is being, well, captured.…more...
The patient-reported outcome company moves its software to a Samsung device with a new form factor and operating system.
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.
Is it finally OK to say that the pharmaceutical industry’s dependence on paper is embarrassing?
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