Applied Clinical Trials-01-01-2004

Applied Clinical Trials

Medicare Drug Coverage to Spur Pharmaceutical R&D

January 01, 2004

View from Washington

After a long, contentious battle, Republicans mustered up enough votes just before Thanksgiving to approve a massive, complex bill designed to overhaul Medicare policies and provide coverage for prescription drugs.

Speeding the Critical Path

January 01, 2004

Feature Article

Pharmaceutical research and development costs are growing faster than the market.1 This trend is important, because pharmaceutical companies finance R&D from a relatively fixed percentage (10%?20%) of global revenues.

Conducting Clinical Trials with Plasma-derived Products

January 01, 2004

Feature Article

The process of conducting clinical trials with plasma-derived products is essentially similar to that for any pharmaceutical product. However, trials with these products do present some different challenges in terms of trial design, patient recruitment, and clinical trial supplies.

What Does a Blackout Have to Do with Being 21 CFR Part 11 Compliant?

January 01, 2004

Latebreakers

Power source Raymond Hecker explains what's required to be 21 CFR 11 compliant, power-wise.