Our GCP team is made up of subject matter experts in clinical quality and compliance. We can provide the following services and more:

• Risk management
• Clinical Quality Manuals and SOPs
• CAPA design and processes
• Clinical Quality System implementation
• GCP qualifying audits for sites and vendors
• GCP audits for ongoing trials, routine and/or for-cause
• Audits of Contract Research Organizations (CROs), Central Labs, IRBs, and Data Management.
• Project Management of audits including end-to-end strategy, document review and system integration.