Our CRO detailed

In order to successfully conduct our clinical trials, we can offer our business partners a multitude of activities due to our highly qualified and engaging team.

Project management

• Draw up of study-designs for clinical trials with medical devices according to national/international regulations
• Recruitment of eligible sites
• Consultancy for the design of Clinical Trial Protocols and CRFs
• Trial planning with Protocol Challenge
• CRF designing
• Support by the sponsor to select explicit sites
• Assistance with contractual arrangements and budget planning

Regulatory Affairs

• Competent submissions of trials according to MPG, investigator Initiated Trials (IITs) and non-interventional trials/ Post-Marketing Surveillance
• Support and acquisition of all essential documents
• Draw up of patient information sheets/informed consents according to all legal requests and regulations
• Support and official reporting of events to the authorities
• Maintenance and remote monitoring of database
• Managing TMF for national and international sponsors
• Draw up and screening of Investigator Site Files

Monitoring / Auditing

• Draw up of Monitoring plans and SOP’s

• Conducting all necessary on-site visits

• Guaranteed reporting of all security relevant issues to the sponsor

• Preparation and support of sites and sponsors concerning inspections and audits

• Official pre-inspection audits

• Conducting of quality audits