investigator Archives

Key Items Auditors Look for When Reviewing an Investigator Site File

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.

Beginner’s Guide to Investigator-Initiated Trials

While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials

Meeting the Challenges of Investigator-Initiated Trials

Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.