In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress levels of everyone involved in clinical trials. Auditing can be looked at as a quality assurance process, and a way to prepare for inspections and approval by:

  • Identifying and addressing issues before the FDA finds them.
  • Preparing for Inspections by reviewing the BIMO checklists and knowing what to expect.
  • Proactively addressing compliance concerns through BIMO preparation audits.
  • Verifying that vendors are qualified to do their jobs.
  • Preparing the research team with mock inspections along with interviewing and coaching sessions.