Theorem Clinical Research

Articles Published in 2010

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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NIH official sees need to evaluate effectiveness of IRBs in protecting study volunteers

Monday, October 18, 2010 07:40 AM

Institutional Review Boards (IRBs) are central to the system of protecting human subjects who participate in clinical research, yet concerns have been raised that there is no way to measure whether IRBs actually do their job of protecting study volunteers from unnecessary risk of harm.

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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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More big pharmaceuticals join trend of partnering with CROs to cut costs, speed drug development

Monday, October 11, 2010 10:27 AM

Major pharmaceutical companies are increasingly forming long-term, strategic partnerships with a small number of global contract research organizations (CROs) in order to cut costs and streamline their outsourced clinical work.

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Massachusetts solidifies position as a haven for biotech jobs

Thursday, October 7, 2010 03:19 PM

Massachusetts has improved its position as a nation-leading biotechnology cluster, increasing jobs not just in research & development, but also in manufacturing. The latest data from MassBio shows Massachusetts was one of just four states that added biotechnology manufacturing jobs in the last decade. Overall, Massachusetts has improved its position within the physical sciences, as defined by industry concentration, by 100 percent.

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FDA issues rule on safety reporting

Tuesday, October 5, 2010 08:51 AM

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. “These changes will better protect people who are enrolled in clinical trials,” said Rachel Behrman, M.D., associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. The new rule requires certain safety information be reported to FDA within 15 days of becoming aware of an occurrence, including: findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions occurring at a rate higher than expected; serious adverse events from bioavailability studies that determine what percentage and at what rate a drug is absorbed by the bloodstream, and bioequivalence studies that determine whether a generic drug has the same bioavailability as the brand name drug. The rule also provides examples of evidence suggesting an investigational product may be the cause of a safety problem. Currently, sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. This complicates and delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported and when to wait for more than one occurrence.

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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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Covance and Sanofi-aventis ink landmark 10-year, $2.2 billion R&D outsourcing partnership

Monday, October 4, 2010 10:01 AM

Hailed as the largest outsourcing partnership between a contract research organization (CRO) and a pharmaceutical company, Covance and Sanofi-aventis have signed a 10-year agreement in which the CRO will provide France’s largest pharmaceutical company with a wide range of research and drug development services, and receive between $1.2 billion and $2.2 billion in revenue.

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The CenterWatch Monthly October 2010

Friday, October 1, 2010 09:04 AM

Anticipating disruptions from sponsor M&As and consolidations

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Covance and Sanofi-Aventis sign 10-year, $2.2 billion strategic R&D alliance

Thursday, September 30, 2010 09:52 AM

CRO Covance, based in Princeton, N.J., today announced the signing of definitive agreements with Sanofi-aventis for a research and development partnership worth up to $2.2 billion.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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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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Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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