Applied Clinical Trials
April 01, 2005
Feature Article
It can be difficult to determine when a hospitalization is "for treatment" and counts as serious under Japanese regulations.
April 01, 2005
Feature Article
Certain clinical project metrics are heavily influenced by country-specific regulations or conditions, such as IEC review times.
April 01, 2005
View from Brussels
A recent conference featured debate on the role of research ethics committees.
April 01, 2005
View from Washington
Clinical trials may take longer and become larger as proposals emerge to strengthen regulatory policies.
April 01, 2005
eShowcase
DigiScript (Franklin, TN) acts like a teacher's college of sorts for study investigators. Managers ensure their staff acts properly in every location, making each independent site unified in its approach to the clinical research at hand.
April 01, 2005
A Closing Thought
With the advent of personalized medicine and purported "race-based therapies" such as BilDil in the news, it is time the pharmaceutical industry makes a more concerted effort to engage racial and ethnic minority groups and the rural poor in clinical research.
April 01, 2005
Feature Article
A delay in receiving one piece of information may have a severe impact on later parts of the process, such as label text.
April 01, 2005
Technology Viewpoint
Technology enables advances in trial design, but it is the creativity of people that really moves things forward.