The balance between privacy and drug discovery

In 2011, Forbes published a somewhat startling article about HIPAA violations in the U.S. The gist  of the piece is that violations are occurring more than one might think, that data that people consider to be non-confidential details are in fact protected by law, and that organizations are being successfully sued for millions of dollars […]

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Cloud infrastructure in imaging trials: the need for quality

In an interesting interview in Bio.IT World, Glen DeVries, president of Medidata Solutions, spoke about the evolution of clinical trial processes and how we’re inevitably going toward cloud solutions. I couldn’t agree more. As Glen points out, we’ve seen this phenomenon across a multitude of industries: The advent of good software packages moved things from […]

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Trusting investigator sites to do the right thing

As we all know, investigator sites around the world are the most important partners a sponsor or a lab can have in their quest to determine the efficacy of new therapies. Investigator sites are small groups of committed researchers and trial coordinators who are dedicated not only to improving their patients current medical condition, but […]

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Moving from media to electronic submissions: Five tips every clinical PM should know

An Operations Project Manager at AG Mednet oversees the customization and deployment of AG Mednet’s exam processing and submission technology to its core lab and pharmaceutical/device customers. The set-up of AG Mednet software for an imaging clinical trial begins with a requirements-gathering process for the application build. The Project Manager works with the Operations Engineers […]

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Clinical trial submissions: Are more images better?

Clinical trials involving imaging endpoints produce significant amounts of digital data. If you compare an imaging trial with one that doesn’t collect medical images, the amount of bits and bytes sent from investigator sites in the former increase by multiple orders of magnitude. While everyone agrees that advanced scanning such as CT, MRI, angiography and […]

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A conversation about clinical trial costs, challenges and opportunities

A report by the Tufts Center for the Study of Drug Development claims it costs $2.6 billion to develop a drug over the course of more than a decade. When the Center conducted the same research in 2003, it cost an estimated $802 million to develop a drug — or the equivalent of $1.04 billion in 2013. So why the 8.5% […]

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Compliance is expensive. Now, go get validated!

I was recently catching up on some of my reading, when I bumped into an article about the FDA cracking down on medical diagnosis apps. Bloomberg talks about an iPhone application that lets users check for blood, protein and other substances in their urine. As the article states, “The app relies on users, such as diabetics […]

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How much does a data query cost?

We all hear about the negative impact data queries have in clinical trials.  Their abundance, which has been described and written about widely, results in a lot of hand wringing and declarations of hope that we can do away with most of them. The questions I am most interested in understanding are: What causes data […]

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The right tools for the job make all the difference

Ask any artist, surgeon, carpenter or computer scientist what, aside from skill, makes them efficient and effective at their job and their answers will be the same. The tools of the trade are what enable them to deliver the best, most consistent results that their skills will allow. Having the right tools for any given […]

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Why we celebrate International Clinical Trials Day

The clinical trial industry is booming with innovation. Researchers, scientists and pharmaceutical sponsors are pushing the limits for what’s possible in drug development and they’re working day and night to bring drugs to market faster; ultimately providing a cure or treatment to patients in need. It’s hard to believe the industry is less than 300 […]

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