Data and Documents

Believe it or not, we have Consultant Auditors that actually enjoy the tedious job of auditing Clinical Study Reports and other documents.

Documents we have reviewed include:

  • Clinical Study Reports for format and accuracy, in comparison to the tables, listings and graphs
  • Audits of the clinical and/or safety database in comparison to reports / submissions to FDA or other government authorities
  • Annual reports to the Regulatory Agency
  • Audits of Trial Master Files and Investigator Site Files, electronic, paper or hybrid
  • Protocols and Amendments
  • Investigator Brochures and Package Inserts
  • Informed Consent Forms
  • Study-specific Plans