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Applied Clinical Trials-04-01-2012
Applied Clinical Trials
Applied Clinical Trials Digital Edition - April 2012
April 01, 2012
Issue PDF
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INFORMATION TECHNOLOGY : Enhancing Risk Assessment and Mitigation REGULATORY : Sunshine Act?s Impact on the Industry Implementation of Objective Internal Monitoring Also in this issue : Impact of Transparency Policies, EMA?s Executive Director Faces Multiple Challenges, The Roles of Healthcare and Research, HIV Vaccine Trials
Business and News Update April 2012
April 01, 2012
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
Transparency, Sunshine Shape Research
April 01, 2012
View from Washington
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Demand for more information on study results and investigator payments create challenges.
When Worlds Collide: Healthcare and Research
April 01, 2012
CTI Insights
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Healthcare and research should pass useful information back and forth whenever possible.
CRO Founded to Address Neglected Diseases in Under Served Countries
April 01, 2012
News
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PHACT is making inroads in drug development for neglected disease.
EFGCP Acts to Reduce Ethics Problems
April 01, 2012
Global News
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The EFGCP has organized a meeting next month in Trondheim, Norway, that will focus specifically on complex cases.
Sunshine Act's Impact
April 01, 2012
Feature Article
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The amendment addresses data concerns for both physicians and drug/device manufacturers.
Keeping a Cool Head Amidst Turmoil
April 01, 2012
View from Brussels
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The new Executive Director of the EMA has managed to stay calm under financial and political pressure.
ERT and UCLA Partner for Postmarket Study on Chronic Obstructive Pulmonary Disorder
April 01, 2012
News
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ERT and UCLA partner in postmarket studies with an eye toward telehealth.
Startup Offers New Take on Recruitment
April 01, 2012
News
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A new service is launching at the end of the month that should help make recruitment easier.
Risk Assessment and Mitigation
April 01, 2012
Feature Article
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A quantitative approach to enhancing risk assessment and mitigation in drug development.
Budgeting a Complex Trial
April 01, 2012
News
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Allison Burmeister discussed the average cost increase based on the per patient cost in a clinical trial during her presentation at the ExL Pharma C.R.O.W.N. Event.
Industry Metric Indicates Low ROI with Full Source Document Verification
April 01, 2012
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There's a rapidly growing trend towards targeted (or risk-based) site monitoring and data review. However, some organizations remain concerned about the potential impact on data quality.
Objective Internal Monitoring
April 01, 2012
Feature Article
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Sponsors are responsible for monitoring studies, patient safety, and data integrity.
HIV Vaccine Trials: Safe for All
April 01, 2012
A Closing Thought
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Researchers who work on HIV vaccines face a major challenge: convincing members of at-risk communities to volunteer for these trials.
Legal Risks to Consider in Virtual Trials
April 01, 2012
News
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The benefits to virtual trials seem endless.