Applied Clinical Trials-02-01-2011

Applied Clinical Trials

Applied Clinical Trials Digital Edition - February 2011

February 01, 2011

Issue PDF

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INFORMATION TECHNOLOGY : A Risk-Based Approach for Computer Systems Validation SITES : Trial Monitoring - Source Document Verification REGULATORY : FDA's Guidance on Patient-Reported Outcomes ALSO IN THIS ISSUE : FDA's Oversight Capabilities Increased, Influenza Warning Issued, Cloud Computing: A Reality?, Guidance Says Focus on the Patient

Applied Clinical Trials Digital Edition - February 2011, Supplement

February 01, 2011

Issue PDF

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eClinical Trials Collaboration Challenge Integrated Technology Manage Trial Master Files via Investigative Portals Directory

Hispanics Remain Minority in Clinical Trials

February 01, 2011

News

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Though they are the largest minority in the country, Hispanics remain underrepresented.

State Cash Fuels Growth in England

February 01, 2011

Global News

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Patient participation increased drastically in England in 2010.

Biosimilars in the US & EU Regulatory Pathways

February 01, 2011

News

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FDA met in November to discuss the biosimilar regulatory guidance.

Cardiovascular Drug Trial Discontinued

February 01, 2011

Therapeutic Corner

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Merck's cardiovascular drug vorapaxar study was halted.

Targeting Source Document Verification

February 01, 2011

Feature Article

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Monitoring of clinical trials is a federally mandated responsibility of trial sponsors and a core offering of contract research organizations (CROs) that is crucial to the validity of clinical research.