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.
Subject safety and reliability of data are paramount in clinical research. This blog outlines what auditors look for when performing source data verification (SDV) and source data review (SDR) during routine investigator site audits.
Different types of audits can be performed to support your vendor qualification and management program. These audits should be conducted using a risk-based approach. In this blog, we outline the difference between these types of audits and how to identify vendors that have the most potential risk for your program.
