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