Project Management
Team Approach – We streamline our team according to the sponsors' needs
Concerning the planning, coordination and supervision of all trial related activities, our Project Managers put great emphasis on daily communication with their partners in the sponsors' project teams. The close relationship creates a suitable atmosphere for an open exchange of views amongst all concerned and also guarantees that possible problems during any phase of a trial can be identified and solved at an early stage.
Our project managers are actively involved in all aspects of clinical trial management:
- Protocol review
- Writing the patient information and informed consent
- CRF design
- Investigator selection
- Pre-study visits
- Handling site budgets and contracts
- Handling of Clinical Trial Applications (CTAs) to competent authorities and ethic committees
- Handling regulatory submissions
- Coordinating investigator meetings
- Setting up monitoring plans, source data verification checklists and patient status tracking
- Site initiation visits
- Interim monitoring visits to sites and pharmacy
- Reporting to sponsor, newsletters to sites
- Assistance with recruitment issues
- Maintenance of trial master files (TMF)
- Organise, track and run study budgets
- Close-out visits to sites
- Coordination of Data Management, Statistical and Medical writing tasks