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Applied Clinical Trials-06-01-2011
Applied Clinical Trials
Applied Clinical Trials Digital Edition - June 2011
June 01, 2011
Issue PDF
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CRO/SPONSORS : Integrated Drug Safety Archiving in the United Kingdom Language and Culture in Global Trials INFORMATION TECHNOLOGY : Cloud Computing - Pharmacovigilance TRIAL DESIGN : Placebo Effect of Transdermal NSAIDs SITES : IRB Registration SUBJECT RECRUITMENT : Formula for Recruitment Success Also in this issue : e-Submissions Gain Support, Personalized Medicine, iPad Apps for Clinical Trials, R&D Productivity
Patient Recruitment Feasibility
June 01, 2011
Feature Article
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Defining clinical trial feasibility and establishing a formula for patient recruitment success.
Archiving Approach in the UK
June 01, 2011
Feature Article
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The proper storage of research documents remains an essential aspect of the clinical trials process.
Taking Clinical Computing in Hand
June 01, 2011
Technology Viewpoint
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New iPad apps could allow study participants to access and record information instantly and efficiently.
Business and News Update June 2011
June 01, 2011
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
Getting Personal Over Personalized Medicine
June 01, 2011
View from Brussels
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A potential solution for many, personalized medicine still faces economic, regulatory, and cultural challenges.
Early Use of Antiretrovirals May Reduce HIV Transmission
June 01, 2011
News
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Those who took the ART immediately saw a 96% reduction in HIV transfer to their partner.
Moffitt Cancer Center Chooses Oracle
June 01, 2011
News
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The center looks to Oracle to support translational research and accelerate the development of personalized cancer care.
Current Challenges of Poor R&D
June 01, 2011
A Closing Thought
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Transfer of material between the supply cahins can be time consuming and complicated
Placebo Effect of Transdermal NSAIDS
June 01, 2011
Feature Article
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The implications and challenges of the placebo effect on regulatory agency product approval.
Language & Culture in Global Clinical Trials
June 01, 2011
Feature Article
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With more clinical trials conducted overseas, sponsors are facing new obstacles.
EMA Seeks to Fine-Tune Official Register
June 01, 2011
Global News
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The new online register will help patients access trials information more easily.
Integrated Drug Safety
June 01, 2011
Feature Article
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Creating a drug's safety profile through the use of benefit-risk assessments during development.
Strong Growth in Biopharmaceutical Approvals
June 01, 2011
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Biotechnology is delivering substantially higher numbers of new product approvals. During the period 2000 to 2009, 65 biopharmaceutical products received US marketing approval, nearly double the number of products approved during the 1990 to 1999 period and five times the 1980 to 1989 level.
FDA Gains Support for e-Submissions Standards
June 01, 2011
View from Washington
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CER funding boosts agency informatics initiatives that promise to modernize research and review processes
Ins and Outs of IRB Registration
June 01, 2011
Feature Article
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Registration is required for FDA-regulated IND studies, but is it needed for non-IND studies?