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August 29, 2008

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. 

Liver Net

CTI: Focussing On Hepatitis

A Cincinnati-based CRO plans to stay medium-sized and private, despite a tidal wave of work that has started to come its way. 

Rocket Man

On NASA, BBC and GSK

The industry’s image takes another hit in Britain. Unsolicited advice on avoiding similar encounters.

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Productivity Enhancement

Nextrials Has Clinical Take On iPhone

December 20, 2007

The modern clinical trial is built around a 2,000-year tool invented by the Chinese. Paper. Case report forms. Signatures. Binders of paper. Trucks filled with paper. FDA warehouses trembling under the heft of it. Some industries might be ashamed. Not ours. In the life sciences, every self-respecting company can talk… more...

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Custom Training DVDs

Lights, Camera, Enroll!

December 17, 2007

In a hurry to dramatically increase enrollment for a trial? Have traditional methods lost their effectiveness? Then consider a custom DVD for principal investigators and other research staff. It will get them more invested in what you’re doing and simultaneously provide compelling instruction. Instead of the usual monotonous production featuring… more...

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Goal: Improve Investigator Ties

Wyeth’s Site Initiative

November 02, 2007

There’s no doubt about it. Site relationship management (SRM) has taken big pharma—and big biotech, for that matter—by storm in the last year. Where there are large, bureaucratic companies developing drugs, there are new SRM initiatives. And conferences on it now abound. But just what is SRM? Each sponsor and… more...

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New Source Of Tension

Clinical Trial Startup Fees

October 15, 2007

The people at Fast Track Systems are experts at the detailed analysis of clinical trial budgets by cost item, medical specialty or geographic area. The company has 25,000 protocols in its database, and adds perhaps another 4,000 annually. It offers software, services and data that help sponsors design and budget… more...

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Clinical Data Repositories

Laszlo Tackles The Future, Part II

October 10, 2007

Yesterday, in a separate story, we talked with consultant George Laszlo about clinical data repository (CDR) functionality and terminology. This article is more forward-looking, and mentions some choices and long-term benefits for a CDR. Laszlo thinks the industry should ponder where clean clinical trial data should live. How easily will… more...

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Clinical Data Repositories

Laszlo Tackles The Future, Part I

October 09, 2007

Is the data-handling part of the pharmaceutical industry being inexact in its use of some key terms? Is it preparing intelligently for the future? Consultant George Laszlo wonders. On the terminology front, he says sheer sloppiness is obscuring some of the most urgent priorities. His question: where exactly should the… more...

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Litigation Protection

Clinical Trial Insurance

August 14, 2007

If you’re a small sponsor getting ready for a clinical trial, plan on shelling out at least $10,000 to $25,000 more per year than the actual cost of that study. This is not for investigators who suddenly want more money, or for extra recruiting efforts. It’s for clinical trial insurance.… more...

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Scary Slides, Numbers From Getz

Site Profit Two Percent, Says Tufts

August 08, 2007

No wonder it’s hard for pharma and biotech companies to find and retain good clinical sites. Basic arithmetic and common courtesy are still sinking in. According to numbers from the Tufts Center for the Study of Drug Development (CSDD), on paper, clinical sites make 9 cents in profit for every… more...

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Making Ends Meet

Bridge Loans for Clinical Sites

July 26, 2007

Greg Seminack got a call from a friend who distributed drugs to clinical sites. He was deep in the finance world at the time. Seminack’s buddy mentioned that many of the sites he visited were in dire straits financially. Yes, they had contracted with some of the largest, most profitable… more...

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‘Conservative’ FDA, Frets Ruffolo

Redefining Productivity At Wyeth

July 23, 2007

Sitting there in Arlington, Virginia, at the ExL Pharma meeting on clinical trial design, we had an unexpected humanitarian pang. Was it cruel to put Robert Ruffolo, Wyeth’s president of research and development, on the program? Yes, Ruffolo has been making the rounds of the conference circuit for years. But… more...

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