Applied Clinical Trials-06-01-2010

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Applied Clinical Trials

June 01, 2010

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

Applied Clinical Trials
A Closing Thought

June 01, 2010

The 12-year data exclusivity period has significant implications in delaying the launch of biosimilars.

Applied Clinical Trials
Business News

June 01, 2010

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

Applied Clinical Trials
A Closing Thought

June 01, 2010

There is still an endemic inefficiency in health care and clinical trial record connectivity.

Applied Clinical Trials
Feature Article

June 01, 2010

Overcoming method validation challenges for trial populations during biologic drug development.

Applied Clinical Trials
Feature Article

June 01, 2010

The financial advantages of using ePRO over paper-based diaries when conducting clinical trials.

Applied Clinical Trials
Feature Article

June 01, 2010

New survey from Tufts CSDD and Applied Clinical Trials provides an inside look at global sites.

Applied Clinical Trials
View from Brussels

June 01, 2010

New guidelines are being developed in Europe to address questions regarding stem-cell medicines.

Applied Clinical Trials
Global News

June 01, 2010

The newest report from the European Forum for Good Clinical Practice identifies the widely diverse ethical approval system across Europe.

Applied Clinical Trials
Feature Article

June 01, 2010

Step-by-step process for budgeting global trials that uses a Currency Risk Management method.

Applied Clinical Trials
Phase News

June 01, 2010

Updates on the respiratory therapeutic market.

Applied Clinical Trials
Feature Article

June 01, 2010

Guidance for auditing quality systems of independent ethics committees throughout Europe.

Applied Clinical Trials
Feature Article

June 01, 2010

Employing a three-component risk exclusion model in the assessment of investigational drugs.

Applied Clinical Trials

On several occasions each year, Industry Standard Research (ISR) has the opportunity to speak with sponsor companies about their outsourcing practices.

Applied Clinical Trials
Feature Article

June 01, 2010

Even before trials start, compiling a "target label" can add value by helping steer product development.

Applied Clinical Trials
View from Washington

June 01, 2010

FDA eyes risk approaches to site inspections to use resources more efficiently.

Applied Clinical Trials

June 01, 2010

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Applied Clinical Trials
Technology Viewpoint

June 01, 2010

What it can mean for the future of health care studies and how it can benefit clinical trials' patients.

Applied Clinical Trials
Feature Article

June 01, 2010

Cultural, technological, and practical issues that need to be addressed to increase success.