Applied Clinical Trials-07-01-2003

Applied Clinical Trials

Biomarkers and Surrogate Endpoints in Clinical Drug Development

July 01, 2003

Feature Article

Both large and small pharmaceutical companies have learned that the value of their development candidates increases once clinical research has demonstrated their proof of concept. Sponsor companies face the challenge of moving new blockbuster drugs to market as rapidly as possible.

Clinical Monitoring: Answers to Questions about Good Clinical Practice

July 01, 2003

A newly published reference guide answers a wide variety of GCP questions.

21 CFR 11 Compliance at Investigator Sites

July 01, 2003

Feature Article

CRAs now have to monitor sites? compliance with FDA?s Electronic Record, Electronic Signatures regulation.

EU Pediatric Rules ?Creeping Like Snail?

July 01, 2003

View from Brussels

The issue of prioritizing clinical trials of pediatric medicines continues to simmer, as plans for planning the possible future legislation develop.

Meet the EAB: John Vogel

June 01, 2003

Meet the EAB

John Vogel, clinical researcher turned consultant, is passionate about outsourcing. He believes that pharmaceutical companies can gain competitive advantages through drug development outsourcing.