Data Based Predictions
In the age of international trials, data drives the selection of golden sites and investigators to get it right.
Research Disclosure Rules Raise Questions
FDA, NIH, and sponsors all struggle to implement complex registration and data access requirements.
Note to File (NTF) is Not an FDA Panacea
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.
Making Reality of Pediatric Rhetoric
Some of the tangible outcomes expected to emerge from a pediatric network include scientific and operational quality standards.
In Search of Efficiency Between Trial Phases
Today's sponsors are waking up to the fact that changes made between phases can positively impact R&D.
Improving Subject Recruitment
Effective contingency planning requires implementing small but critical seeds at the outset of a study.
