May 26, 2019dickensian

Intralinks Survey

With Paper, Site Pain

June 15, 2011

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...

Clinical Ink's Tablet

New Esource Platform

March 30, 2011

The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials.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...

DIA Web Seminar

FDA Pushes For E-source

March 03, 2011

Late last year, the FDA released a draft guidance on electronic source, or "e-source."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...

$400 Million Niche

Imaging Core Lab Nuances

September 03, 2010

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...

7 Questions For Core Labs

Modern Imaging Benchmarks

August 18, 2010

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...

Dictionary Quandary

5 Definitions of “Eclinical”

January 06, 2009

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...

Magic Pen

Kayentis: Back to The Future

November 24, 2008

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...

Top '08 Talk

Realizing (Or Missing) EDC’s Potential

May 08, 2008

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...

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.

Evolutionary Biology 101

Etrials Booth Tragedy

Is it finally OK to say that the pharmaceutical industry’s dependence on paper is embarrassing?

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