History
Mark has been in Clinical QA for over 12 years and in this time has inspected or audited most GCP
processes. As a GCP Inspector, Mark was involved in over 140 inspections covering Commercial
Sponsors (43), Non-Commercial Sponsors (30), Contract Research Organisations (14), Phase 1 Units
(5), niche providers (5) and Bioequivalence Units (4). The inspections also involved 40 investigator
sites.
As an auditor, Mark has conducted in excess of 150 audits / projects. These are subdivided as shown
below:
| Audit/Project Type | Number |
|---|---|
| Investigator Site Audits (ISAs) | >100 |
| Mock GCP Inspection (MHRA , EMA and FDA based) | 44 |
| Training Projects | 32 |
| Laboratory (Local / Central / Bioanalytical and Specialist) | 17 |
| Phase 1 Units | 20 |
| Research Ethics Committees (RECs) | 8 |
| Contract Research Organisations (CROs) | 32 |
| Data Management / Statistics | 10 |
| Local Affiliate Offices | 7 |
| Interactive Response Technology (IRT) Systems | 5 |
| Internal Systems, e.g. Medical Expertise, Regulatory | 7 |
| Trial Master File (TMF) | 5 |
| QA Consultancy | 5 |
| Clinical Study Report (CSR) | 3 |
| Electronic Data Capture (EDC) Systems | 1 |
| Document Management Systems (DMS) | 1 |
| Specific Documentation Audits | 1 |
| PK Modelling and Simulation | 1 |
| GMP | 1 |
| GLP Lab | 1 |