Simultaneously implementing clinical trials at different trial sites is an extensive undertaking: On the one hand, it is necessary to recruit and bring together the appropriate trial sites and a variety of suitable patients. On the other hand, qualified Study Nurses are required to supervise clinical trials and thus serve as an interface between physicians and research – both in a medical and administrative sense.
Invisio supports national and international sponsors/CROs in multicenter clinical trials in Germany, Austria and Switzerland by taking over the entire project management. To ensure that clinical phase 1 to phase 4 trials in the EU run smoothly, Invisio relies on its pool of both domestic and foreign partner centers as well as more than 120 qualified Flying Study Nurses.
We work closely with doctors and clinics that are interested in conducting trials, as this allows us to know their patient base and demonstrate good recruitment practices. If needed, we can also acquire further trial sites to meet individual trial requirements.
As the project manager, we take care to ensure that your national or international clinical trial runs smoothly and achieves success. In order to live up to this claim, our project management includes the following services and more:
- Acquisition and simultaneous management of several trial centers within the EU
- Establishing and maintaining a professional GCP/ICH infrastructure on-site
- Recruitment, coordination and care of patients
- Interface between project participants, organization of relevant dates, monitoring of schedule and budget
- Selection of a team of Invisio Flying Study Nurses, who are in charge of all initiated sites
- Travel and deployment planning with a view to holiday periods / substitutes in case of illness
- Training of the study assistants on-site / online / at the sponsor’s facility / in the Invisio-Office
- Familiarization of the Invisio Flying Study Nurses with the study protocol and the procedures of the trial centers
- High safety standards: Server location in Germany, highest possible level of SSL encryption and redundant server system
- No external hosting: Administration of study documents on own server
- Monitoring and compliance with GDPR guidelines within the studies
- Contract and accounting for Invisio Flying Study Nurses
- Processing of insurance for study assistants
- Central contact person for questions regarding the project process
How Invisio ensures the quality of its services
- Regardless of the location, Invisio employs only trained study personnel.
- The same internal guidelines and Standard Operating Procedures (SOPs) for Invisio Flying Study Nurses apply in all countries.
- Project-specific SOPs and work instructions prepare the Invisio Flying Study Nurses for their specific activities.
- All Invisio Flying Study Nurses speak the respective national language fluently or at native speaker level.