September 3, 2010e-diary, epro, palm

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Differentiation Via Psychometrics

Ediaries & The Z Axis

August 09, 2010

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...

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Rapid Launches

CRF’s New eDiary King

January 02, 2009

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...

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R U Txtng Px Yet?

Pfizer Picks Exco SMS

December 12, 2008

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...

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Automating eDiary Quality

Arrowhead, Bayer Win SCDM Award

September 29, 2008

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...

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Invivodata Claims Third Of Market

Site Surge: ePRO Update

August 20, 2008

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...

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A Digital Clipboard

New invivodata Tablet

May 21, 2008

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...

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E-PRO Niche Expands

Diary Alliance: ClinPhone & invivodata

May 01, 2008

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...

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Florida Conference

Deep invivodata Dive On Diaries

April 07, 2008

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...

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.

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.

Industrywide EDC Adoption

Rising Phoenix Data Systems

The vendor says its success is attributable to a comprehensive offering, reliably delivered—oh, and the problems of competitors.

Firm Boasts 5 Approvals

PHT Diary Bookings Rise

The patient-reported outcome company’s chief, Phil Lee, discusses why his firm is thriving and electronic diaries are so popular.

Productivity Enhancement

Nextrials Has Clinical Take On iPhone

Hardly a gimmick, Nextrials’ use of the Apple iPhone could make overworked site staff and monitors like their jobs a bit more.

GSK's Checklist for PRO

Patients, In Their Own Words

Highlights from a recent Center for Business Intelligence conference on patient reported outcomes.

Friday News Briefs

Phase Forward In India

With news about Ranbaxy, Cedara, PHT, ChemDiv and etrials


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