Most clinical data integrity findings don't start with fraud. They start with unreviewed audit trails, late source entries, and records that don't match the EDC. For sponsors and CROs ...
Clinical software systems can be installed, configured, and implemented in daily use without ever having gone through validation. This is the gap GCP auditing services are designed to find. ...
Having reviewed documents for sponsors, CROs, and investigator sites for eight years, I've noticed something constant. The people who deal with the data often know about the issues. They ...
Finding: "Documentation did not accurately reflect actual site practice." Six words. These six words mean months of remediation, a late submission, and sponsors wondering how no one saw this ...
