Applied Clinical Trials-06-01-2011

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

Defining clinical trial feasibility and establishing a formula for patient recruitment success.

The proper storage of research documents remains an essential aspect of the clinical trials process.

New iPad apps could allow study participants to access and record information instantly and efficiently.

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

A potential solution for many, personalized medicine still faces economic, regulatory, and cultural challenges.

Those who took the ART immediately saw a 96% reduction in HIV transfer to their partner.

The center looks to Oracle to support translational research and accelerate the development of personalized cancer care.

Transfer of material between the supply cahins can be time consuming and complicated

The implications and challenges of the placebo effect on regulatory agency product approval.

With more clinical trials conducted overseas, sponsors are facing new obstacles.

The new online register will help patients access trials information more easily.

Creating a drug's safety profile through the use of benefit-risk assessments during development.

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.

CER funding boosts agency informatics initiatives that promise to modernize research and review processes

Registration is required for FDA-regulated IND studies, but is it needed for non-IND studies?