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Applied Clinical Trials-02-01-2011
Applied Clinical Trials
Applied Clinical Trials Digital Edition - February 2011
February 01, 2011
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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
Rates Increase Abroad Due to High Demand
February 01, 2011
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Asia, Latin American, and Eastern Europe are increasingly attractive geographies in which to conduct clinical research.
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.
The FDA's Guidance on PRO
February 01, 2011
Feature Article
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This guidance has both raised the stakes and improved the odds of securing label claims based on PROs.
H1N1 Influenza: Not to be Sneezed at
February 01, 2011
View from Brussels
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Renewed pandemic fears drawn the sting from criticisms of industry and regulators.
Cardiovascular Drug Trial Discontinued
February 01, 2011
Therapeutic Corner
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Merck's cardiovascular drug vorapaxar study was halted.
New Approach to System Validation
February 01, 2011
Feature Article
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Considerations in implementing a risk-based framework for computer systems validation.
The Patient Matters: Thanks FDA
February 01, 2011
A Closing Thought
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The guidance has driven the industry to take note of the patient-to listen, understand, and document.
Business and News Update February 2011
February 01, 2011
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
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.
Are We Ready to Fly into the Cloud?
February 01, 2011
Technology Viewpoint
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Cloud computing is now becoming possible for pharmaceutical companies, but still faces challenges.
Changes at FDA and Challenges on Capitol Hill
February 01, 2011
View from Washington
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Congress readies probes of FDA practices, while FDA seeks transparency and organizational changes.