We perform audit and education services, as follows. Please inquire if you need additional or other services.
Audit services:
• Sponsor, Monitor, and CRO audits,
• Investigational Research Site audits,
• GCP Compliance audits [Drug, Biologic/Vaccine],
• Audit Non-Clinical Laboratory audits [GLP],
• cGMP audits [selected focus areas],
• Medical Device audits,
• Pharmacovigilance and Drug Safety,
• Submissions [Paper / Electronic],
• Electronic Systems,
• Computer Systems Validation
• Determination of Fraud
• ALCOA+ Compliance
• Policy and SOP audits
Educational services:
• GCP Training
• GLP Training
• Preparation for Inspection
• Corrective and Preventative Action Training
• Computer System Validation Training
• Electronic Document Handling
• How to Write Effective Policies and SOPs
• Clinical Research Management
• Management Responsibility 101
• Fraud Identification in Clinical Research
• 'Mock Inspections'