Project management including submissions
To verify efficiency and safety of new therapies it is necessary to test them systematically under controlled conditions. Beyond proven therapy success, it is also essential that the clinical trial is compliant with given quality standards and legal regulations in order to obtain market authorization.
This is exactly the target our enterprise is aiming at: We provide our clients the service of experienced monitors who represent the interface between sponsor and clinical investigators and who play a leading role in guaranteeing compliance with given quality standards in clinical research. At the same time, we see it as our responsibility to ensure that monitors possess specific qualifications to conduct an expert supervision of the clinical trial.
In addition to monitoring, we offer our clients the service of project managers who accompany and support them in all study related matters from the planning phase to publication in order to ensure that the project is carried out successfully.
Our service range includes
- Trial logistics and assurance that all timelines and authorities’ requirements are fulfilled in line with AMG, GCP/ICH, MPG
- Process of submission to competent authority and ethics committee
- Protocol development
- Conduction of monitoring according to monitoring plan by experienced, highly motivated and socially competent monitors, who work according to sponsor or company SOPs
- Creation and processing of trial documents and auxiliary materials
- Selection of qualified study sites/clinical investigators
- All-inclusive offer, comprising all services and travel expenses