In addition to our in-house services we offer the full range of GCP quality support for your systems and Phase I to IV trials:

• Auditing of
• clinical studies Phase I to IV
• CROs and vendors
• special services, e.g. central lab, central ECG, blinded reads, ePRO, PK-lab
• internal systems
• Support in implementing quality management systems
• Preparation of authority inspections, e.g. by FDA or EMEA
• Training on GCP and related topics, CFR/FDA regulations and auditing

Our GCP Consulting Group is headed by Alexander Both who held various management positions in the area of international GCP auditing and quality management in the pharmaceutical and CRO industry in Germany and the United States.