Good Clinical Practice (GCP) audits are regularly conducted in order to assess and diagnose any issues of compliance of the clinical trials with the study protocols, GCP standards, and other applicable regulatory requirements.
At EuroPharm, our priority in on-site and remote GCP audits is to make sure patient safety is not breached and good monitoring systems are in place to assure the quality, reliability, and integrity of the documented and shared data. In addition, Phase I facility and study audits are performed on request in order to ensure that structure of the facilities or on-going studies are compliant with appropriate regulations and standards.
EuroPharm Consulting team has conducted remote audits even before COVID-19 against the GCP and GVP regulations.
Our GCP audits can be interest to:
- Pharmaceutical companies
- Biotechnology companies
- Medical device producers
- Service companies (CROs)
- Clinical sites