GCP-Auditing
GCP-Service performs project audits for you in order to review the quality of the study performance within mono and multi-centre studies. This service includes the review of study compliance in terms of:
- Ethical norms
- Laws (physicians law, drug law)
- Regulations
- ICH GCP
- ISO 14155 Parts 1 and 2
- Contractual agreements
Additionally, GCP-Service offers independent system audits at your selected CRO. This audit includes a comprehensive review of key documents such as SOPs, training documents and other documents relevant for the quality of implemented systems.
Generally the purpose of audits conducted by GCP-Service is to improve the quality of clinical studies, independent of the audit location. If necessary, investigator staff may be provided with further training on ICH GCP, drug law and regulations in a constructive and mutually beneficial way.
The QA managers of GCP-Service have more than 13 years of clinical research experience. They can support you with risk management in your company, and we can help to develop efficient systems capable of reducing risk and enhancing in-house quality.
