Applied Clinical Trials-02-01-2011

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Applied Clinical Trials

February 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

Issue PDF
Applied Clinical Trials

February 01, 2011

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

Applied Clinical Trials

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

News
Applied Clinical Trials

February 01, 2011

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

Global News
Applied Clinical Trials

February 01, 2011

Patient participation increased drastically in England in 2010.

Applied Clinical Trials

February 01, 2011

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News
Applied Clinical Trials

February 01, 2011

FDA met in November to discuss the biosimilar regulatory guidance.

Applied Clinical Trials
Feature Article

February 01, 2011

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

Applied Clinical Trials
View from Brussels

February 01, 2011

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

Therapeutic Corner
Applied Clinical Trials

February 01, 2011

Merck's cardiovascular drug vorapaxar study was halted.

Applied Clinical Trials
Feature Article

February 01, 2011

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

Applied Clinical Trials

February 01, 2011

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Applied Clinical Trials
A Closing Thought

February 01, 2011

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

Applied Clinical Trials
Business News

February 01, 2011

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

Applied Clinical Trials
Feature Article

February 01, 2011

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.

Applied Clinical Trials
Technology Viewpoint

February 01, 2011

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

Applied Clinical Trials
View from Washington

February 01, 2011

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