Applied Clinical Trials-03-01-2008

In the age of international trials, data drives the selection of golden sites and investigators to get it right.

FDA, NIH, and sponsors all struggle to implement complex registration and data access requirements.

Carl Anderson, senior consultant for Biologics Consulting Group, addresses the frequent overuse of Notes to File and concludes that documenting a mistake means absolutely nothing during an FDA inspection.

Some of the tangible outcomes expected to emerge from a pediatric network include scientific and operational quality standards.

Today's sponsors are waking up to the fact that changes made between phases can positively impact R&D.

Effective contingency planning requires implementing small but critical seeds at the outset of a study.