Applied Clinical Trials-11-01-2012

Will ethics committees buy into the radical new approach of latest draft regulation?

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Tufts CSDD

Industry news focusing on the people and organizations who work in the clinical trials profession.

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A framework is needed to facilitate, promote, and reward basic and applied research for adults and children.

A countdown of the top 10 developments that have most influenced the ePRO industry over the past decade.

In late August, the FDA elevated the Office of Generic Drugs to report directly to Janet Woodcock, the director of CDER.

Medidata

Study coordinators see responsibilities increase dramatically while salary levels remain flat.

A mid-year summary of the European Medicines Agency's 2012 activities underlines the growing trend toward closer collaboration between international regulators.

Recommendations for assessing translatability.

Meeting FDA requirements: the electronic collection of suicidal ideation and behavior data.

The key to accelerating drug development, according to numerous experts, is to revise requirements that generate lengthy, complex, and costly clinical trials.

The opportunities and challenges social media provides in the realm of subject recruitment.

Subject Recruitment: Recruitment Through the Use of Social Media Also in this issue: EU Regulation Protocol Study Coordinator Survey Development of Pediatric Drugs