The Glamor Factor
iPhones for Sites from assisTek
Using a tablet PC and the Apple phone, assiTek says larger screens can be helpful to science and sites.
Safety. Efficacy. Are those two cardinal notions of clinical development enough? Jean Paty has a third. He believes it is as central as safety and efficacy. Paty is co-founder and senior VP of scientific, quality and regulatory affairs at invivodata, a Pittsburgh, Penn., electronic patient diary firm. If safety and efficacy are the X and Y axes of clinical development, patient experiences are its Z axis. "The Z axis has always been there," says Paty. "Patient-reported outcomes (PRO) are just a subset of the endpoints that we capture in trials." What's shifting, he says, is that the FDA is trying to re-emphasize how sponsors can quantify those patient experiences. The FDA's final guidance on the topic (in PDF format here) was published late in 2009, and it was in draft form for several eternities before that. Even so, industry's regulatory affairs professionals and senior clinicians may have not absorbed the document's…more...
CRF has noticed a funny thing about patients filling out clinical trial diaries in India and eastern Europe. The data are immaculate. The patients are highly compliant, to the tune of…more...
Say you need someone to do something for you in Singapore. It turns out it’s rude to leave someone a few voice mail messages. Even several email requests are a bit…more...
We were in Dallas last week. The 2008 Society for Clinical Data Management (SCDM) conference presented an award for “data-driven” innovation. The format of the award is to assess what a…more...
It’s easy to get bedazzled by smartphones that can deliver patient-reported outcomes (PRO). But that may not be the most common way that the industry is trying to record such data. The Pittsburgh e-diary company, invivodata, has examined some 5,000 clinical trials from the 2007 time frame in clinicaltrials.gov. Using that data, its own projects, and those…more...
Sponsors are willing to spend to make sites’ lives easier. Tablet PCs for electronic patient-reported outcomes (ePRO) seem to be an increasingly popular means to that end. Earlier this year, PHT announced a tablet for clinical trial sites. assisTek has had a tablet for a while. Now Pittsburgh’s invivodata is getting into the act. The firm had…more...
They were going to the same meetings. Seeing each other in the same airports. Bidding on the same projects. One thing lead to another. Then, just yesterday, ClinPhone and invivodata announced a global marketing alliance for electronic patient-reported outcomes. The press release is here. It’s the latest sign that the ePRO sector is getting hot. Evidently there…more...
In the latest sign that the Palm platform will no longer be the sole major entrant in the clinical trial arena, invivodata is expected to preview a Windows-based tablet computer. The occasion: the company’s 2008 user meeting, to be held April 29-May 1 in Boca Raton, Florida. Palm is a sponsor of the event, as it turns…more...
Using a tablet PC and the Apple phone, assiTek says larger screens can be helpful to science and sites.
The patient-reported outcome company moves its software to a Samsung device with a new form factor and operating system.
The vendor says its success is attributable to a comprehensive offering, reliably delivered—oh, and the problems of competitors.
The patient-reported outcome company’s chief, Phil Lee, discusses why his firm is thriving and electronic diaries are so popular.
Hardly a gimmick, Nextrials’ use of the Apple iPhone could make overworked site staff and monitors like their jobs a bit more.
Highlights from a recent Center for Business Intelligence conference on patient reported outcomes.
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