Study Conduct

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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Site Solutions survey: Lack of operating capital, cash flow plague investigative sites

Monday, November 15, 2010 09:17 AM

Sixty percent of investigative sites have less than three months of operating cash on hand in the bank, according to the 2010 Site Solutions Summit survey.

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U.S. Chamber of Commerce mission to India focuses on collaboration, innovation in growing biosimilars market

Monday, November 15, 2010 09:10 AM

As drug development grows ever more global, India continues to stand out as one of the key places to be. And with President Barack Obama having just wrapped up a high-profile, economic-focused trip to India last week, it’s clear that doing business with and in this country is a top priority across many sectors.

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CISCRP takes its AWARE educational events for clinical research nationwide with webcast Saturday

Tuesday, November 2, 2010 07:00 AM

This Saturday, Nov. 6, the Center for Information & Study on Clinical Research Participation (CISCRP) will host its first national live AWARE web broadcast. The goal: to use a combination of the web and personal interaction to educate the public about the importance of understanding and participating in clinical research.

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P.I.s used blood transfusions to help patients meet eligibility criteria for clinical trials

Monday, November 1, 2010 09:38 AM

A group of hospitals in Toronto has discovered principal investigators (P.I.s) among their ranks giving blood transfusions to patients in order to alter their lab values to better match inclusion criteria for clinical trials.

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Site Solutions Summit honors Eli Lilly, PPD with Eagle Awards

Wednesday, October 20, 2010 02:19 PM

The complexity of today’s clinical trials, the regulatory burdens and the disease states being tackled make the current drug discovery market a difficult one in which to operate, Dr. Jeffrey Kasher, vice president of clinical development organization for Lilly Research Laboratories at Eli Lilly, told more than 350 industry members last Saturday evening at the Site Solutions Summit in Clearwater Beach, Fla.

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Goodwyn IRB launches “site university” to apply good clinical practices to real-life situations

Tuesday, October 19, 2010 07:50 AM

In the 11 years since she founded Cincinnati-based Goodwyn IRB, Ellen Kelso says she’s noticed a great deal of non-compliance among investigators on the trials she’s overseen. Those making the mistakes had good clinical practices (GCP) training, but they somehow weren’t able to apply it to real-life situations in the course of a trial, she said.

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Quintiles expands its Prime Site program with Arizona State, South Korea strategic partnerships

Tuesday, October 12, 2010 10:21 AM

Global CRO Quintiles has stepped up expansion of its Global Prime Site program, which forms research partnerships with large hospitals and health systems capable of enrolling hundreds of clinical trial patients each year. Having established prime sites in California and Asia earlier this year, Quintiles has now signed strategic partnerships with Arizona State University (ASU) and the Seoul National University Hospital (SNUH), increasing its number of prime sites to seven.

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Nonprofit group takes its cue from online gaming to find innovative ways to speed medical research

Tuesday, October 5, 2010 07:47 AM

The hyper-intense focus and problem-solving prowess of a person playing an online game can be a thing of beauty. But can that focus be harnessed to speed up the drug development process?

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