June 24, 2018regs

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High Performance Trials

Lundbeck: Attainable Efficiencies

October 26, 2010

There is one small, nettlesome wrinkle in the way most clinical trials are budgeted. Studies in the same program, therapeutic area or company may not be as similar in cost as senior managers expect. Can one trial's budget be xeroxed and become the starting point for another? "That doesn't always turn out to be the case," sighs Tim Viohl, manager of drug development at Lundbeck. Viohl is based in Deerfield, Illinois, near Chicago. Lundbeck's headquarters are in Copenhagen, Denmark. With 5,900 employees (430 in the U.S.), it boasts a $600 million annual research budget. Viohl joined the company as part of the acquisition of Ovation Pharmaceuticals in early 2009. ClinicalTrials.gov shows that Lundbeck has listed 15 actively recruiting Phase III trials, with an average of 342 patients in each. The company is working in Alzheimer's, stroke and other central nervous system (CNS) conditions. This 718-patient alcohol dependence study is being run…more...

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Part One

Sites+EDC=Pain

July 08, 2010

Electronic data capture (EDC) systems allow sponsors to gather data electronically. In theory, that should be cheaper and faster. After a decade of gradual acceptance of the technology, all sponsors have…more...

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Site Aid

Patient Debit Cards

May 04, 2010

Karen Hultberg was frustrated. The administrator of the New York Hospital Queens' Lang Research Center was trying to do more studies. But there was a big obstacle: for each research subject's…more...

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Star Quintiles Site

Proactive Piedmont Medical

March 11, 2010

We asked Quintiles to tell us about one of the most improved sites or site networks in its five-year-old partner sites program.Piedmont…more...

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Swine Flu Boon

Encorium Plugs On

November 12, 2009

Another Encorium deal has bitten the dust. The beleaguered contract research organization (CRO) recently announced that its recent attempt to sell its Finnish subsidiary Encorium OY to an unnamed CRO in the U.S. is scuttled. In a release, the company stated that, on the heels of $8.7 million in new business contract wins thanks to its selection…more...

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Space Doubles

Quintiles Central Lab Expands

October 02, 2009

The economy isn't getting Quintiles down. The mammoth contract research organization (CRO) just announced that it has consolidated its operations in Scotland into one brand new, state of the art, built-to-suit, 115,000-square-foot building. The new structure cost about $15 million to build. Quintiles is renting. Tom Wollman, senior VP of global central laboratories for the Research Triangle-based…more...

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Exit Strategy

MDS Pharma To Be Sold

September 04, 2009

Just two months after selling off Phase IIb-IV operations to Inc Research, MDS has announced that it's trying to sell everything else it's got left in the clinical research sector. Earlier this week, the Toronto-based firm announced it was looking for buyers for what remains of MDS Pharma Services. That includes Phase I through Phase IIa proof-of-concept…more...

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A Quick History

India’s Regulation Timeline

June 19, 2009

The regulatory system in India is maturing quickly. Just a few years ago, it was said to be in its infancy—with drug makers and contract research organizations (CROs) largely having to regulate themselves. Now it is an adolescent, and growing up fast. To explain where India's been and where it's going with respect to regulating clinical trials,…more...

Friday News

Excel, PFC Pharma Team Up

Bulletins from Generex, Arena, Campbell Alliance and UCB.

Thursday News

Felony Trial Charges

Bulletins from Durect, Icon, Protox, INC Research, Matrixx Initiatives, Phase Forward and the U.S. Attorney’s Office in Philadelphia.

Sale to Charles River

PPD Acquires, Divests

PPD sells off its preclinical subsidiary and simultaneously buys a small dermatology-focused biotech firm.

Pushing East

PPD to Acquire AbCRO

PPD discusses its pending $30 million purchase of AbCRO, a women-owned firm with a strong base in Eastern Europe.

Finding Quality and Speed

IRB Selection Tips

Not sure how to choose an IRB? We’ve got a list.

Profiling PPD & Mmatiss

A Tale of Two CROs

PPD, Brazil’s largest CRO, and Mmatiss, one of its many diminutive ones, tell us what business is like in the fifth largest country in the world.

Faster Launches

Brazil’s Regs

Soon, Brazil may no longer have the second-longest trial start-up time on earth.


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