Phone: +49 2171 36 33 6-0

Expertise - Project management

Project management

We view project management as the key to a successful study. Our staff are the primary contacts for our customers and study centers in all aspects of the study. As such they coordinate with you, but also with other members of the study team, about all necessary and agreed-upon project processes. All staff members have years of experience in the support of clinical studies as well as sound knowledge in the areas of study planning, the development and coordination of project procedures, in addition to applicable regulatory guidelines. The tasks in this area include:

  • Preparation of the necessary study documents and paperwork
  • Approval process by the federal authority and the ethic commission
  • Reports (in accordance to §67 AMG) for sponsors, testing centers, study physicians as well as all further contributing institutions
  • CRF-design in collaboration with the areas of medical writing, data management, and biometrics
  • Preparation of the centers and training of the study monitors
  • Compilation of reports about the course of the studies
  • Support of the entire team in adherence to regulatory guidelines and standards
  • Organization and execution of study meetings
  • Control of deadlines and resources
  • Coordination of all project processes