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 14155:2011 as well as 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. For more information please click here.