Applied Clinical Trials-04-01-2005

It can be difficult to determine when a hospitalization is "for treatment" and counts as serious under Japanese regulations.

Certain clinical project metrics are heavily influenced by country-specific regulations or conditions, such as IEC review times.

A recent conference featured debate on the role of research ethics committees.

Clinical trials may take longer and become larger as proposals emerge to strengthen regulatory policies.

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.

What’s on your mind?

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.

A delay in receiving one piece of information may have a severe impact on later parts of the process, such as label text.

Technology enables advances in trial design, but it is the creativity of people that really moves things forward.