Applied Clinical Trials-01-01-2004

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.

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.

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.

It may be known as "the old continent," but Europe sure as hell comes up with plenty of new rules.

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