Applied Clinical Trials-06-01-2010

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

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

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

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

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

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

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

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

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

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

Updates on the respiratory therapeutic market.

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

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

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

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

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

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

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