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October 10, 2008

Diagnostic Inspiration

Almac Launches Discovery Effort

Using genomic expertise, the Almac Group starts a search for its own compounds. 

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.

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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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Ken Getz At DIA

Tufts Data: Veteran P.I.s Drop Out

July 19, 2007

In countries outside the U.S., principal investigators who elect not to do any more trials are usually the nervous newbies. That’s not a shock. What is surprising is that here in the U.S., those leaving clinical research, never to return, are—ouch—the seasoned veterans.  That’s according to Ken Getz, senior research… more...

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Who Should Not Recruit?

Clarification: Pfizer Site Strategy

July 11, 2007

After a complaint from Pfizer, we’ve updated a recent story about DIA. There’s a link to our first story at the bottom of this article. It’s clear ClinPage accurately quoted Andy Lee, Pfizer’s vice president of clinical study and data management. He and the company do have concerns about sites… more...

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Epic Lawsuit: Sargon v. USC

When A Trial Went To Trial

July 05, 2007

A dentist with a new idea for dental implants approaches an academic medical center about conducting a one-site study. Sounds like an ordinary arrangement. It was anything but. Almost two decades later, the dentist and the university are still embroiled in a legal fight so bitter and complicated that it… more...

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Our Revised Story

Pfizer: Dance With Only Me

June 29, 2007

Editor’s note: This story has been revised since it was posted on June 29, 2007. Contrary to our initial article, Pfizer has never asked any site to choose between working for Pfizer and another sponsor. As it explained at DIA, however, Pfizer is guiding more sites and investigators to either… more...

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BBK’s Freebie Generates Buzz

DIA Swag of Choice

June 25, 2007

“A major manufacturer is interested in funding your Phase II study. Collect $150.” “Investors are impressed with your Phase I results. Collect $50.” “Discover new reptile saliva extract that offers a potential cancer treatment. Collect $150.” It’s all part of “Monopoly: The Clinical Research and Development Edition,” a creative (and… more...

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Evolutionary Biology 101

Etrials Booth Tragedy

June 22, 2007

In the animal kingdom, the vivid plumage of a tropical bird is (for other birds) a reliable indicator of the creature’s health and reproductive vitality. Likewise, the size and splendor of a trade show exhibitor’s booth is an indicator of the financial health of the company sponsoring it. If elk… more...

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