Services IGQC

• Full service CRO audits
• Vendor audits (e.g. Pharmacovigilance, Data Management, Laboratory)
• Computerized system audits (e.g. Data Management Systems, Safety Database, Trial Master File)
• "Mock-audit", to prepare for an upcoming inspection or sponsor audit

• Develop / implement Quality Management System
• Define the actual company/study processes
• Quality Control of company SOPs
• Develop the required SOPs
• Provide support as an Interim Quality Assurance Manager

• Implement Monitor procedures for clinical trials
• Provide monitor training

• Good Clinical Practice (ICH GCP)
• Inspection readiness
• Company specific SOPs
• Training and coaching monitors / CRAs
• Training and coaching Clinical Trial Assistants