An audit is a Quality Assurance function which is independent, and has a top-down systematic evaluation on the risks and opportunities for continuous improvement. We can provide stand-alone audits or create in close consultation with the client a comprehensive audit plan.

GCP 

- Investigator Site Audit
- Phase I Unit Audit
- (Internal) System Audit
- TMF/ISF/PF Audit
- Vendor Audit (pre-qualification and in-process audit) in e.g. Project Management, Monitoring, Data Management & Statistics, Medical Writing, Central Reading Validation for Intended Use Audit (e.g. IVRS, EDC)

GLP (lab)

- Central/Local Laboratory Audit
- Method Validation Audit
- Bioequivalence Audit

GLP (pre-clinical)

- Vendor Audit (pre-qualification)
- Support QA Unit at test facilities with in-process audits:

• Study specific Audits (e.g. protocol review, critical phase audit, final report audit
• Process Based Audits (e.g. animal husbandry, sample handling, routine testing)
• System-wide Audits (e.g. Organisation/Personnel/Training, Facility & Equipment, Test/Control Articles, Methods & Control)

Pharmacovigilance    

- (internal) System Audit
- Central/Local PV functions
- ICSR Quality Assessment
- Aggregate Report Assessment
- Vendor Audit (pre-qualification and in-process audit)
- License Partners
- Validation for Intended Use Audit (e.g. Global Safety Database)