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

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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