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May 17, 2008

Fixing A Twisted System

For-Profit Conferences: Evil or Essential?

The conference industry should borrow an idea from the medical journals, our guest author says.

IND Ethics Loophole

Circare: Academic Patient Advocate

University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed.

Fewer, Smarter Trials

TrialStat’s SRS For Systematic Reviews

Though not widely used in industry, the systematic review could help it use resources more efficiently.

A-List Of Speakers At Harvard

Post-Approval? Or Pre-Apocalypse?

With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year. 

Expert View

Why Data Managers Can Lead

Bayer’s Rob Musterer reflects on a widening mission for the data manager.

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A-List Of Speakers At Harvard

Post-Approval? Or Pre-Apocalypse?

April 08, 2008

Maybe it’s the medical school ambiance. Or the end of a long Boston winter. But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings. It’s a little cozier. More intimate. The conference is held in the spring in an auditorium at Harvard Medical… more...

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Expert View

Why Data Managers Can Lead

March 28, 2008

Outsource, outsource, outsource. It seems to be a mantra that has hit even clinical trials these days. The list of companies with significant data management outsourcing seems to keep growing. Wyeth, Eli-Lilly, AstraZeneca, Pfizer, to name a few. How is it that this situation has arisen? From a variety of… more...

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BioWorld Tallies Biotech Pay

Amgen, Genentech Pay Highest

March 25, 2008

Amgen is the place to work, apparently. That’s if you consider the 2008 Executive Compensation Report, just published by BioWorld. It shows the Thousand Oaks, CA-based firm’s CEO, CFO and COO all garnered the highest compensation for their positions in the landscape of publicly traded biotech firms in the U.S.… more...

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CTC Conference Report

More Patients? Or Fewer Trials?

March 24, 2008

The 2008 Clinical Trials Congress had deep tracks of sessions around patient recruitment and trial budgeting. The familiar paradox is that as more sponsors seek more patients, patients become even more scarce. But now that conventional wisdom seems to be upside down. Instead of the familiar refrain of more patients,… more...

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Anticipating 600,000 Queries

Updated Medidata EDC Offering

March 17, 2008

Hold on to your desk. A major electronic data capture (EDC) vendor recently announced a revision to its technology that is ... entirely internet based. This was similar to announcing the development of a stone wheel that is ... round. It’s fine to brag about a round wheel with a… more...

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The Glamor Factor

iPhones for Sites from assisTek

March 14, 2008

We read a surprising statistic the other day. According to market research firm NPD Group, Apple’s iPhone has blazed past Microsoft and Motorola in less than a year, capturing 16 percent of the smart phone market. It’s now second only to the Blackberry from RIM. Among all cell phones, Apple’s… more...

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Using Fewer Sites

Recruitment Powerhouse: Synexus

March 12, 2008

On Sept. 30, 2004, the day Merck withdrew Vioxx from the market, Lancashire, England’s Synexus Clinical Research was working on the biggest Vioxx trial ever.  “I nearly jumped out my office window,” jokes CEO Michael Fort. The Vioxx saga turned out to be a blessing for the company, however. The… more...

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Expert View

Patient Recruitment in 2008

March 07, 2008

As the industry continues to expand, and strains to meet ever-more challenging timelines and budgets, the state of the art in patient recruitment remains an urgent topic. But 2008 promises to be a period of continued exploration of how to find appropriate patients as efficiently as possible. We foresee the… more...

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Working Together

Alliance Management At Abbott

February 28, 2008

Jargon and catch phrases grate on our ears like fingernails on a blackboard. Plain old English is enough. Important-sounding buzzwords are designed to conceal the underlying ideas, not illuminate them. But in the case of “alliance management,” a phrase that sounds new to our weary ears, we may have to… more...

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Several NIH Projects

Open Source EDC From Akaza

February 26, 2008

The pharmaceutical industry is seemingly in agreement that electronic data capture (EDC) is a good idea. Even obligatory. But let’s back up: what is EDC? Is it software? If so, why can it cost hundreds of thousands of dollars to get every trial started? Is EDC more properly considered a… more...

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