Theorem Clinical Research

Articles Published in 2010

Survey: relationship between FDA and life sciences industry deteriorating, delays in review process cited

Monday, December 13, 2010 07:00 AM

Top biopharmaceutical company executives are frustrated with delays and inconsistencies in the Food and Drug Administration (FDA) regulatory review process and are concerned that passage of the healthcare reform law, which gave the already resource-constrained agency more responsibilities, will further complicate drug approvals, according to a new PricewaterhouseCoopers (PwC) survey.

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It’s holiday bonus time—or is it? Investigative sites split on ethics of bonuses

Friday, December 10, 2010 01:44 PM

For many workers, December is not just the holiday season. It’s the season of the holiday bonus.

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Grassroots advocacy uses family relationships,trust to bolster patient recruitment

Monday, December 6, 2010 08:20 AM

Patient recruitment often creates an insurmountable bottleneck for trials. But could that be because many sponsors and CROs are overlooking more grassroots-style ways of carrying it out?

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Via Science creates predictive models to help sponsors better use complex research data

Monday, December 6, 2010 07:16 AM

New “big data” analytics company Via Science will market technology that allows drug sponsors to use the massive amount of complex data generated in research when making decisions about their drug development candidates and strategies.

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Roche to cut 4,800 jobs in global restructuring plan

Thursday, December 2, 2010 11:18 AM

After absorbing Genentech, Swiss pharma giant Roche has announced its cost-cutting plans, much of which will take place in manufacturing and sales. But there will also be some significant trimming in R&D.

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The CenterWatch Monthly December 2010

Monday, November 29, 2010 12:30 PM

Pessimism and instability defining the clinical research workforce

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Small biotechs receive $1 billion in U.S. tax credits, grants to create jobs, speed drug development

Monday, November 29, 2010 09:18 AM

Nearly 3,000 small biotechnology companies have been awarded a total of $1 billion in government tax credits and grants to help speed the development of promising new therapies, create jobs and maintain U.S. leadership in biotechnology innovation.

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MyClin offers virtual communities for sponsors, CROs, sites to stay connected during trials

Monday, November 29, 2010 09:00 AM

At the investigator meeting prior to the start of a clinical trial, principal investigators and their staffs sit together to hear the sponsor explain the protocol and to ask questions. Everyone socializes over snacks or a meal, connecting faces to names and discussing the ins and outs of the trial.

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FDA: Generic transdermal patches should be tested in divergent climates

Monday, November 22, 2010 09:06 AM

A patch that delivers medicine transdermally may act very differently on a resident of Fargo, N.D., than on someone in South Florida. Thus, the amount of medicine that enters their bloodstreams may be different. That’s the assertion of the FDA’s Office of Generic Drugs, and that’s why the regulatory body now asks that drug developers working on transdermal patches—at least in the generics realm—test their patches in multiple divergent climates.

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Lack of recruitment, missed patient visits among new researchers’ common mistakes

Monday, November 22, 2010 09:01 AM

Some private-practice physicians who decide to conduct clinical trials can have trouble meeting enrollment goals because they forget to speak with their patients about study participation. Others inadvertently miss a patient visit and have to fill out numerous forms explaining why they deviated from the clinical trial protocol. 

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CWWeekly

October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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