Applied Clinical Trials, Nov 1, 2012 - Applied Clinical Trials

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Applied Clinical Trials, Nov 1, 2012
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View from Brussels
Taking the Pulse of Ethics Committee Views
By Peter O'Donnell
Will ethics committees buy into the radical new approach of latest draft regulation?
Feature Article
Social Media Recruitment
By Christine Andrews
The opportunities and challenges social media provides in the realm of subject recruitment.
News
Generic Drugs Making Waves
By Lisa Henderson
In late August, the FDA elevated the Office of Generic Drugs to report directly to Janet Woodcock, the director of CDER.
Regulators, Sponsors Seek to Streamline Research
By Jill Wechsler
The key to accelerating drug development, according to numerous experts, is to revise requirements that generate lengthy, complex, and costly clinical trials.
EMA's Mid-Year Report Merits Scrutiny
By Philip Ward
A mid-year summary of the European Medicines Agency's 2012 activities underlines the growing trend toward closer collaboration between international regulators.
Patient Reported Outcomes
Capturing Suicidal Patient Data
By Michael Federico
Meeting FDA requirements: the electronic collection of suicidal ideation and behavior data.
The Local Touch
By Barbara A. Brandt , Matthew Talbert
Recommendations for assessing translatability.
ePRO Industry Growth
By Phil Lee
A countdown of the top 10 developments that have most influenced the ePRO industry over the past decade.
Business News
Business and News Update
By Hannah Becker
Industry news focusing on the people and organizations who work in the clinical trials profession.
CTI Insights
Are CRCs Reaching Their Tipping Point?
By Kenneth A. Getz
Study coordinators see responsibilities increase dramatically while salary levels remain flat.
A Closing Thought
Pediatric Drug Development
By Klaus Rose
A framework is needed to facilitate, promote, and reward basic and applied research for adults and children.

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Europe Faces Persistent Gaps in International GCP Inspections
What Do Risk-Based Monitoring and Patient Engagement Have in Common?
Social Media for Clinical Trials Professionals Tweet Chat
Will Congress Provide Sequester "Flexibility" for User Fees?
PCORI Launches Clinical Research Network to Support Trials, Outcomes Research
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