We conduct your clinical trial according to the medical device directive, the medical device law, the DIN EN 540 and all other applicable laws and regulations.

Clinical trial planning

• Protocol development
• CRF-Design
• Develop subject tracking system
• Recruitment of investigators and sites
• Assistance in obtaining the votes from the institutional 
  review board/independent ethics committee
• Announcement of the study
• Assistance in obtaining the CE-Mark

Monitoring (according the Sponsors SOP's)

• Study-Start and Initiation - Visit
• Fee-Agreements
• Monitoring-Reports
• Status-Reports
• Recruitment of the security agent
• Final status reports
  

Data processing

• Database development
• Independent double-data-entry
• Data-cleaning and query processing
• Delivery of the final database to the sponsor