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Linking Up

Diary Firm invivodata Touts CRO Partners

October 16, 2006

The diary firm says 10,000 people are now certified to use its platform. That’s a five-fold increase since the program was started. The company’s network of contract research organizations (CROs) is also growing, and now includes 8 of the top 10 CROs. A few partners include Dendrite International, VIASYS Healthcare…more...

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Early Warning

Deeper Data Mining

October 16, 2006

A U.S.-Israeli firm, Business Events, claims to be able to perform data mining on all of a large company’s data. News accounts neglect to say how they load all of a large company’s data. But a story online is interesting because the principals behind Business Events got their start in…more...

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Higher standards

Canadians Tighten Trial Rules

October 16, 2006

Authorities in Canada are changing the rules for clinical trials. They’re taking a more proactive stance than colleagues in Britain, which saw 6 patients severely injured in a clinical trial earlier in 2006. (In the most serious case, one British patient lost his fingers and toes.) The Canadians have implemented…more...

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Looking West

Parexel Buys California Firm

October 13, 2006

Parexel International acquired the California Clinical Trials Medical Group for $65 million. Founded in 1981, California Clinical Trials Medical Group (CCTMG) has 180 employees and is based in Glendale, California, where one of four facilities has 16 exam rooms. The firm does research in trials from Phase I-IV. CCTMG says…more...

In The Clinic Now

Whither Nano @ FDA?

October 12, 2006

Earlier this week, the FDA heard two expert views on nanotechnology. The number of products the FDA has already approved using nanotechnology? Nine, including Abraxane, Acticoat and Estrasorb. The prepared remarks made at the FDA are online. The blog nanotechwire brought this to our attention and has an interesting story…more...

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Data Management & More

Asian CRO Picks Phase Forward

October 12, 2006

Clinical data management is not really an endangered species. But it is threatened. That’s because some companies believe that massive, traditional systems to manage clinical trial data could be made obsolete by electronic data capture (EDC) tools that do some of the same tasks. An Asian contract research organization (CRO)…more...

Wall Street

News Flash: Analyst Likes Life Sciences

October 12, 2006

Just defining the life sciences can be controversial. For one Wall Street analyst, life sciences firms only help with drug discovery and do not participate in it themselves. Citigroup’s Elise Wang says the life sciences are finally poised for growth. Perhaps the cycle is turning again, with once-hot companies warming…more...

Euro News

Sparta Systems Touts EMEA Project

October 12, 2006

How electronic should the offices of regulatory agencies be? On the one hand, they’re accustomed to paper. They have no legal mandate to require electronic submissions, only the ability to gently encourage the industry to move toward electronic systems. The FDA is certainly doing that. But as the FDA’s own…more...

Fleet of Foot

Covance Moves Arizona Lab In Phoenix Suburb

October 10, 2006

Animal rights activists in the Phoenix area had threatened to block a 300,000 square foot testing facility planned by Covance. The new facility was to employ 300-500 workers at first, and expand to 2,000. At the last minute, in a news conference with unusual security, Covance stunned the Arizona animal…more...

Tool for ANDA's

FDA Expands Submission System

October 09, 2006

Generic drugs will now get the same FDA system that has been used to track applications for new drugs. The FDA system has a pretty exciting name, DFS, which stands for Division File System. It’s been used by CDER and its Office of New Drugs for six years. But the…more...

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January 8, 2009

Monday News

PRA Expands In Mexico City

Bulletins on Pharm-Olam, Kika, breast cancer award, PRA, medical ghostwriting, ACRP and the Shanghai Clinical Research Center.

Friday News

Pentagon Drug Safety Project

Bulletins on Icon, Isis, AAALAC, MDS Pharma, DataTrak, Pantheon, and PhaseForward.

Thursday News

Thermo Fisher Facility In India

Bulletins on MDS, Cmed, Roche, Bio-Imaging, AG Mednet, Decision View and Thermo Fisher Scientific.

Wednesday News

Agenda for Clinical Trials Congress

Bulletins on Parexel, SITS, Cortia, asthma, SeraCare, PDL Biotech and the Clinical Trials Congress.

Monday News

ThotWave Joins CDISC

Bulletins on ThotWave, CDISC, FDA, AstraZeneca, APP Pharmaceuticals, Velos, University of Kansas, VirtualScopics and ISSCR.

Friday News

UK Pfizer Picks Exco Gadgets

Bulletins on Decision View, OpSource DIA, PRA, FDA, WebMD, Phase Forward and Pfizer UK.