Applied Clinical Trials-02-01-2011

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

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Asia, Latin American, and Eastern Europe are increasingly attractive geographies in which to conduct clinical research.

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

Patient participation increased drastically in England in 2010.

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FDA met in November to discuss the biosimilar regulatory guidance.

This guidance has both raised the stakes and improved the odds of securing label claims based on PROs.

Renewed pandemic fears drawn the sting from criticisms of industry and regulators.

Merck's cardiovascular drug vorapaxar study was halted.

Considerations in implementing a risk-based framework for computer systems validation.

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The guidance has driven the industry to take note of the patient-to listen, understand, and document.

Industry news focusing on the people and organizations who work in the clinical trials profession.

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.

Cloud computing is now becoming possible for pharmaceutical companies, but still faces challenges.

Congress readies probes of FDA practices, while FDA seeks transparency and organizational changes.