Taking the Pulse of Ethics Committee Views
Will ethics committees buy into the radical new approach of latest draft regulation?
Survey Results of Start-Up Cycle Times
Business and News Update November 2012
Industry news focusing on the people and organizations who work in the clinical trials profession.
Act Insert cover
Pediatric Drug Development
A framework is needed to facilitate, promote, and reward basic and applied research for adults and children.
ePRO Industry Growth
A countdown of the top 10 developments that have most influenced the ePRO industry over the past decade.
Generic Drugs Making Waves
In late August, the FDA elevated the Office of Generic Drugs to report directly to Janet Woodcock, the director of CDER.
In the Race to Capture Clinical Data, Does Data Quality Suffer?
Are CRCs Reaching Their Tipping Point?
Study coordinators see responsibilities increase dramatically while salary levels remain flat.
EMA's Mid-Year Report Merits Scrutiny
A mid-year summary of the European Medicines Agency's 2012 activities underlines the growing trend toward closer collaboration between international regulators.
The Local Touch
Recommendations for assessing translatability.
Capturing Suicidal Patient Data
Meeting FDA requirements: the electronic collection of suicidal ideation and behavior data.
Regulators, Sponsors Seek to Streamline Research
The key to accelerating drug development, according to numerous experts, is to revise requirements that generate lengthy, complex, and costly clinical trials.
Social Media Recruitment
The opportunities and challenges social media provides in the realm of subject recruitment.
Applied Clinical Trials Digital Edition - November 2012
Subject Recruitment: Recruitment Through the Use of Social Media
Also in this issue:
EU Regulation Protocol
Study Coordinator Survey
Development of Pediatric Drugs
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