Applied Clinical Trials-08-01-2002

Applied Clinical Trials

Cross-(Dys)Functional Teams

August 01, 2002

Process Improvement

Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.

Checking In on Children, Checking Up on Files

August 01, 2002

View from Brussels

Many stakeholders have already commented on the EU?s incentives for pediatric drug development.

eSource Redux

August 01, 2002

Technology Viewpoint

Paul Bleicher shares his regulatory philosophy and perspective and defends his position regarding eSource, in response to June?s Guest Commentary.

New User Fee Program Aims to Spur Drug Development

August 01, 2002

View from Washington

PDUFA III boosts manufacturer fees to expand postapproval surveillance and support new FDA review initiatives.

Developing New Drugs in 1000 Days

August 01, 2002

Feature Article

Everybody wants faster cycles and and quicker turnarounds with NDAs. In the U.S., will it soon be possible to go from testing to approval in 1000 days?

Paper vs. Electronic Diaries

August 01, 2002

Feature Article

Studies show that electronic diaries get better results than paper diaries. These authors explain why.