Meet the ethical and scientific standards for Good Clinical Practice.

When conducting clinical trials on investigational medicinal products or devices, you are required to show the planning, study conduct, performance, monitoring, auditing, analysis, and reporting all meet the ethical and scientific standards for Good Clinical Practice (GCP).

Failing to adequately meet GCP standards can threaten the data collected, the future of your products and your reputation within the industry.

As new technologies transform the way clinical research is carried out around the world, keeping ahead of these trends is no small task. Whether you follow a traditional approach to monitoring, or are transitioning to a Risk-Based Monitoring (RBM) system, our quality professionals tailor their auditing plans to accommodate your particular needs.

How we can help

Our quality professionals closely examine your particular study before planning and executing study-specific GCP audits of protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports. With the help of experienced industry professionals, you can be confident knowing results are credible and accurate while maintaining quality practices throughout the research.

  • Mock BIMO Inspections
  • Auditing and document review for SOPs, clinical GCP protocols and reports
  • Audits of submission for ethical approval for GCP clinical trials
  • Audits of clinical sites
  • Audits of Trial Master Files (TMFs)
  • Audits of Contract Research Organizations (CROs) and other vendors

Clinical trial audits are tailored to your particular compliance needs and stage of product development. Our Quality Assurance team has performed audits in a variety of markets both domestic and international.

Contact The FDA Group today for a GCP audit consultation