Monitoring und Auditing mit Qualitätsanspruch
Gesellschaft Unabhängiger Monitore mbH

SERVICES

Our offer:

Study-coordination:

- Investigator recruitment
- Project-Management
- Submission to ethics-committees
- Notification of regulatory authority
- Conception of investigator agreements


Monitoring:

- Monitoring of phases II – IV and of NIS and PAS -studies
according to EU ICH-GCP Guidelines by certified CRA´s
- Investigator training
- Monitoring of kinetic-studies
- Experience with FDA studies
- Continuous status-reports


Auditing:

- GCP - Audits

- Preparation and support for upcoming FDA - and EMA - inspections

- Preparation and support for upcoming inspections of German authorities according to german drug law § 64 (AMG)

- GMP - Audits