thumbnail
Dictionary Quandary

5 Definitions of “Eclinical”

January 06, 2009

Honestly? The word has tormented us. We are talking about “eclinical.” The once-technical term is now routinely being referenced on calls with Wall Street analysts. Google has zillions of links to it. We finally decided to wrestle with it in our own way. To facilitate a serious journalistic contemplation of “eclinical,” we purchased an 80 oz. (5…more...

thumbnail
Tuesday News

Merck Sells Lab To PPD

January 06, 2009

Investor’s Business Daily says that pharma’s investments in biotech companies may not make sense until the FDA determines how to handle generic biotech products. Here’s the article. Will patients be more open to clinical trial participation in a terrible economy? The evidence is anecdotal but growing, says this wire service article. The industry experts quoted say patients…more...

thumbnail
Monday News

Study: Pediatric Psych Trials

January 05, 2009

This article in the Philadelphia Inquirer lists the usual suspects for the top job at FDA, and singles out Joshua Sharfstein as a leading candidate, noting several years of service to an anti-industry politician (Henry Waxman) and an alma mater shared by a good percentage of the Obama team (Harvard). One liability: at the youthful age of…more...

thumbnail
Friday News

Oncology In Phase I Paper

January 02, 2009

Patient recruitment firm Integrated Clinical Trial Services announced a new consulting program. The company said the program “allows pharmaceutical, biotechnology or medical device sponsors to better communicate key information regarding new products and medical therapies to the medical community through contracted healthcare consulting professionals. The MSL process can strengthen a product or therapy’s market penetration by properly…more...

thumbnail
Rapid Launches

CRF’s New eDiary King

January 02, 2009

CRF has noticed a funny thing about patients filling out clinical trial diaries in India and eastern Europe. The data are immaculate. The patients are highly compliant, to the tune of doing 95-98 percent of what they’re supposed to. Rachael King, the new CEO at CRF, isn’t sure what cultural factors explain that performance. “It’s very hard…more...

thumbnail
Wednesday News

FDA Prescription Insert Worries

December 24, 2008

Covance revised its financial projections for 2009. It now expects full-year 2008 earnings to be $3.02 per share, not $3.18. “Despite the fact that both the volume and dollar value of proposal activity for our late-stage service offerings are increasing in the fourth quarter on a sequential and year-on-year basis, we are experiencing reduced demand for our…more...

January 8, 2009

Reorg, New CEO

etrials: Technology Will Be Key

A conversation with Denis Connaghan of etrials, who recently became the new CEO of etrials.

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.

Monday News

Almac GMP Stamp For All Global Sites

A few news bulletins on Illumina, Patheon, Scolr Pharma, Ocimum and Almac.

Interoperable Platform

Medidata’s Eclinical Vision

Glen de Vries of Medidata discusses the company’s effort to create an ecosystem for clinical trial software.

Wednesday News

Medidata Certifies Quintiles

Bulletins on PPD, Parexel, Huya Bioscience, Schering-Plough, Piedmont Medical Group, Icon, Greenway Medical Technologies, Quintiles and Medidata Solutions.

IRBs Are Next

Brazil’s CRO Association

The Brazilian association of CROs helped trim the nation’s regulatory pathway. Now it is hoping for similar efficiencies in the ethical review process.