Auditing Experience
- Investigational sites
- Contract Research Organizations (CROs)
- Sponsors (self- and mock-inspections)
- Trial Master Files (TMFs)
- Clinical study reports
- Analytical laboratories
- Data management / biostatistics
- Investigational medicinal products distributors
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russia, Slovak Republic, Spain, Sweden, Switzerland, Ukraine, United Kingdom, USA (> 120 audits)
QA Experience
- GCP-compliant quality system
- Corrective and preventive actions (CAPAs)
- Standard Operating Procedures (SOPs)
- Inspections by European competent authorities
- Quality assurance documentation
- Consultancy in GCP, regulatory requirements
and study conduct
Clinical Trial Experience
- Clinical trials: phase I-IIIb, first-in-man
- Investigator initiated trials (IIT)
- Non-interventional studies (NIS)
- Pharmacokinetic studies
- Planning and conduct of clinical trials
- Innovative investigational medicinal products
- Key therapeutic areas
- Rare diseases