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Applied Clinical Trials-06-01-2010
Applied Clinical Trials
Applied Clinical Trials Digital Edition - June 2010
June 01, 2010
Issue PDF
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GLOBAL TRIALS : New Survey Baselines Global Sites Keys to Success in China Budgeting for Global Trials European Ethics Committees CRO/SPONSOR : Think About the Drug Label First LABS : 3-Prong Model for CV Safety Immune Response Screens a Necessity eCLINICAL : ePRO?s Tipping Point Also in this issue : FDA?s New Risk Approach to Site Inspections, EMA Speaks to Stem Cell Research, Mother Lode of Latent Research Data
Biosimilars Make Headway
June 01, 2010
A Closing Thought
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The 12-year data exclusivity period has significant implications in delaying the launch of biosimilars.
Business and News Update June 2010
June 01, 2010
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
Electronic Integration Costs
June 01, 2010
A Closing Thought
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There is still an endemic inefficiency in health care and clinical trial record connectivity.
Strategic Immunogenicity Testing
June 01, 2010
Feature Article
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Overcoming method validation challenges for trial populations during biologic drug development.
ePRO vs. Paper
June 01, 2010
Feature Article
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The financial advantages of using ePRO over paper-based diaries when conducting clinical trials.
Today's Global Site Landscape
June 01, 2010
Feature Article
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New survey from Tufts CSDD and Applied Clinical Trials provides an inside look at global sites.
Changing Medicines, Changing Rules
June 01, 2010
View from Brussels
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New guidelines are being developed in Europe to address questions regarding stem-cell medicines.
Ethics Diversity Persists
June 01, 2010
Global News
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The newest report from the European Forum for Good Clinical Practice identifies the widely diverse ethical approval system across Europe.
Mastering Currency Fluctuation
June 01, 2010
Feature Article
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Step-by-step process for budgeting global trials that uses a Currency Risk Management method.
Just Breathe: COPD, Asthma Future
June 01, 2010
Phase News
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Updates on the respiratory therapeutic market.
Differences in Standards for IECs
June 01, 2010
Feature Article
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Guidance for auditing quality systems of independent ethics committees throughout Europe.
Integrated Cardiovascular Safety
June 01, 2010
Feature Article
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Employing a three-component risk exclusion model in the assessment of investigational drugs.
Sponsors Want Therapeutic Experience
June 01, 2010
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On several occasions each year, Industry Standard Research (ISR) has the opportunity to speak with sponsor companies about their outsourcing practices.
Early Labeling Pays
June 01, 2010
Feature Article
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Even before trials start, compiling a "target label" can add value by helping steer product development.
Clinical Trials Face New Enforcement Models
June 01, 2010
View from Washington
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FDA eyes risk approaches to site inspections to use resources more efficiently.
Going With the Flow of Health Care Research
June 01, 2010
Technology Viewpoint
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What it can mean for the future of health care studies and how it can benefit clinical trials' patients.
The China Experience
June 01, 2010
Feature Article
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Cultural, technological, and practical issues that need to be addressed to increase success.