When faced with an FDA inspection, sponsors, CROs and sites must be ready to present trial master files (TMF) that are up to date and give a comprehensive account of the study. And the most efficient way to ensure they are is to maintain a constant state of inspection readiness with a regular TMF review schedule. Read More

Pharma and biotech sponsors are increasingly following the FDA’s lead in using real-world data (RWD) and real-world evidence (RWE) in clinical trials, according to a new survey asking about the most valuable resources for clinical trials. Read More

The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers. Read More

The staffing shortage in clinical research is an undeniable problem that’s only growing worse. Sweeping, radical change is needed to overhaul the current system for hiring new personnel, say industry leaders, particularly regarding restrictive experience requirements that currently bar entry to many promising candidates. Read More