The project manager takes on a key role in every study.
His/her most important task is coordinating the study procedures. Here, we see ourselves as a link between sponsor, the study doctors and the CRA and ensure optimal success. Thus, the project manager carries great responsibility; apart from prompt acting and professional appearance we also pay great attention to the subtle steering of processes. Here, too, our operations are greatly influenced by Dr. Kottmann´s many years of medical experience.
The project management includes all stages of the study and thus ranges from study design to Medical Writing at the end of the project. In cooperation with the sponsor and the Principal Investigator, the project manager takes on all planning and its realisation. Here, great attention is paid to fulfilling the study protocol´s requirements as well as the time and cost-effective implementation of the study. Here we also take on the communication with authorities in charge and the ethics commissions, in order to ensure the required permissions to be obtained promptly.
We attach great importance to close cooperation with the client and offer regular information on all the project developments. Thereby, fast reaction to new circumstances is possible.
The project manager takes on and/or supports the following operations:
- Planning of study design and the entire study procedures
- Choice of qualified study centres
- Drafting of contracts with the study centres
- Organisation of meetings with the study doctors
- Communication with authorities, obtaining permissions and/or ethics votes
- Effecting patients´ insurances
- Drafting newsletters
- Organisation and coordination of statistical evaluations
- Controlling of adherence to timelines and estimated study budget
- Remuneration of study doctors
- Coordination of monitoring
- Communication with the CRA, study centres, the Principal Investigator and the sponsor
Upon request we take subservices or the entire project management.