February 8, 2012ehr

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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The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials.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 that document in the coming years, there could be profound changes in the way that clinical data is collected by the pharmaceutical industry. The biggest potential change? Paper-based facts now filed away in boxes might become electronically accessible to FDA inspectors. With that prospect in mind, Clinical Ink is an interesting company at an interesting juncture in time. The firm is based in North Carolina and makes a $1,500 tablet for clinical trials. The device is being piloted in several small studies. It comes with preloaded medical dictionaries and proprietary software that decodes a user's handwriting in ways custom designed for industry-sponsored research. New Tool Clinical Ink president Ed Seguine formerly toiled in the venture capital and technology branches of…more...

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The eSource Fiasco

What Is An eCRF?

February 03, 2011

"Source" or "esource" could be on the grapevine this year, as sponsors scramble to determine if their systems comply with a new draft guidance from the FDA. It was issued in…more...

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FDA Plea

Next Big Things from Nextrials

November 22, 2010

Nextrials is a small but visionary San Francisco-based electronic data capture (EDC) firm. It had some ideas that took competitors years to duplicate. Nextrials offered built-in patient randomization, drug supply and…more...

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Profile: Target Health

Ending Mindless Monitoring

October 04, 2010

Some contract research organizations (CRO) had to be dragged into using technology. They presented at conferences, pooh-poohing software. They doubted, delayed, complained. They did not necessarily advocate fountain pens and carrier…more...

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Schizophrenic RFPs?

PharmaNet On Late Phase

August 04, 2010

With more than two decades in the industry under his belt, Jeffrey Trotter had his own contract research organization (CRO) for more than a decade. He sold it—twice. And now he's helping to shepherd the late-phase strategy at PharmaNet Development Group, where his title is executive VP, Phase IV development. He supervises a 50-person group dedicated to…more...

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Pfizer's Michael Ibara

Toward A Neutral AE Facilitator

April 23, 2010

Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to the present drug safety morass of paper, faxes, and inefficiency. As head of pharmacovigilance information management at Pfizer, Ibara organized the Aster project, an exploration of…more...

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Pfizer's Warning

Starting Over On Safety

April 22, 2010

If pharmacovigilance were a movie, it would be Groundhog Day, except as a tragedy. Here's the plot. Reports of adverse events (AE) pop up and take years to be evaluated. The associated recriminations bounce between various interested parties. Good drugs exit the market. Bad ones linger. The industry's reputation gets bludgeoned either way. Luck is at work,…more...

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Exclusive: Survey

More Paper, More Burden?

October 19, 2009

Is electronic data capture (EDC) creating inefficiencies? That's one conclusion to be drawn from the interim results of an eClinical Forum survey. Surprisingly, the survey suggests that the use of paper case report forms (CRF) is rising even amid growing adoption of EDC. While most sponsors are committed to EDC, site staff believe it is forcing them…more...

Can Galaxies Merge?

PhRMA Push for EHRs

PhRMA is trying to help the industry understand and tap the potential of systems for electronic health records.

Physician IT Links

Nextrials On The Move

At the age of 10, Nextrials is aiming for an elevated competitive profile and connections to electronic health record (EHR) systems.

The Great Sync

Trial-Friendly EHR Systems

It’s auspicious. Suppliers of clinical trial systems and physician systems are integrating their software. An exclusive chat with Landen Bain.

Webinar, New Guidance

EDC Is Dead? Long Live EHRs?

Thoughts on a potentially transformative alternative to EDC, the electronic health record (EHR).

"No Doctor Left Behind"?

[Leaked] Email To Barack Obama

In a rare gaffe, Barack Obama’s team mis-routes a confidential strategy memo. A sobering look at what one advisor is thinking.

Crowdsourcing Drug Safety

iGuard Turns One

iGuard expected to draw 60,000 members in a year. Instead, it attracted 750,000. The coming shift in strategy—and genomics.

Pondering EHR Access

Relsys: Beyond Clinical Data

Data from physician offices and hospitals is the next frontier in industry’s assessment of drug safety, Relsys asserts.


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