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Trial Design Reform

EDICT Report From Baylor

May 12, 2008

There are not enough minorities, seniors and children included in trials of drugs for minorities, seniors and children. That’s simply bad for society and industry. That’s one of the main thrusts of the Eliminating Disparities in Clinical Trials (EDICT) report, released recently by researchers at Baylor College of Medicine in…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…more...

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Medidata Buys Fast Track

Protocol Optimization and EDC

April 30, 2008

Want science with that? That question hangs over the recent acquisition of 35-employee Fast Track Systems by Medidata Solutions, a leading electronic data capture (EDC) vendor. The deal (but no price) was announced in March. It is an intriguing and potentially game-changing event in the clinical trial technology sector. The…more...

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Fixing A Twisted System

For-Profit Conferences: Evil or Essential?

April 29, 2008

There are a plethora of small conferences in our industry. They address topics as diverse as electronic patient-reported outcomes, (ePRO), eclinical technology, regulatory affairs, patient recruitment and outsourcing. These meetings can be quite broad (the Clinical Trials Congress) or sharply focused (The Advanced Import Compliance Forum). Many of these conferences…more...

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IND Ethics Loophole

Circare: Academic Patient Advocate

April 21, 2008

Every other day, Adil Shamoo says he gets an inquiry about something untoward in a clinical trial. Shamoo, whose day job is professor of molecular biology, epidemiology and preventive medicine at the University of Maryland’s School of Medicine, is also the founder of Citizens for Responsible Care and Research (CIRCARE).…more...

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Fewer, Smarter Trials

TrialStat’s SRS For Systematic Reviews

April 10, 2008

It is not hard to find technologies that the clinical trial community should, by all rights, use. But doesn’t. For whatever cultural or psychological reason. Much like a batty collector of small porcelain figurines, ClinPage counts itself oddly pleased to be able to have found yet another type of software…more...

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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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December 3, 2008

Regional Alliances

Italy, Massachusetts Partnership

Four clinical organizations in Massachusetts have come together to help regions that want to get more of the global medical research pie.

Author Interview

Paxil Lawsuit Narrative

In Side Effects, reporter Alison Bass delves into the New York Attorney General’s 2004 case against GlaxoSmithKline.

Swearing Off Paper?

Electronic Signature Update

The SAFE-Biopharma Association is hoping to nudge the pharmaceutical industry toward a single electronic signature standard.

Redmond's Got Game

Microsoft Tiptoes Toward Clinic

Does Windows have something to contribute to the clinical trial arena? Microsoft asserts its platform is more open and robust.

Pharmica, Merck, Genzyme Strategies

Finding The Right Metrics

What to count (or not), and why.

PharmaNet Outlook Down

S&P On CRO Industry

PharmaNet was downgraded from stable to negative by Standard and Poor’s, thanks to $60 million in lost contracts.