Applied Clinical Trials
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
February 01, 2011
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eClinical Trials Collaboration Challenge Integrated Technology Manage Trial Master Files via Investigative Portals Directory
February 01, 2011
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Asia, Latin American, and Eastern Europe are increasingly attractive geographies in which to conduct clinical research.
February 01, 2011
News
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Though they are the largest minority in the country, Hispanics remain underrepresented.
February 01, 2011
Global News
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Patient participation increased drastically in England in 2010.
February 01, 2011
News
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FDA met in November to discuss the biosimilar regulatory guidance.
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.
February 01, 2011
View from Brussels
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Renewed pandemic fears drawn the sting from criticisms of industry and regulators.
February 01, 2011
Therapeutic Corner
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Merck's cardiovascular drug vorapaxar study was halted.
February 01, 2011
Feature Article
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Considerations in implementing a risk-based framework for computer systems validation.
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.
February 01, 2011
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
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.
February 01, 2011
Technology Viewpoint
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Cloud computing is now becoming possible for pharmaceutical companies, but still faces challenges.
February 01, 2011
View from Washington
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Congress readies probes of FDA practices, while FDA seeks transparency and organizational changes.