Multicenter Studies

Multicenter Studies 

Project management for multicenter clinical trials

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 2 to phase 4 trials in the DACH region run smoothly, Invisio relies on its pool of both domestic and foreign partner centers as well as more than 70 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:

• Trial management
◦ Acquisition and parallel support of several trial sites in the DACH region (other EU countries on request)
◦ Development of a professional GCP/ICH infrastructure according to international standards
◦ Creation of project-related standard operation procedures – SOP
◦ Support in the recruitment of patients
◦ Monitoring and compliance with GDPR guidelines

• Data security / document management
◦ Administration of trial-relevant documents on the company’s own server
◦ Internal domain where documents are made available to project partners
◦ Compliance with high security standards – e.g. server location in Germany, highest possible SSL encryption and redundant server system
◦ Advice on data protection issues

• Human resources management
◦ Operational planning in consideration of vacation periods and replacement in the event of illness
◦ On-demand training of Flying Study Nurses (on site or online)
◦ Travel planning for Flying Study Nurses

• Administration
◦ Contract and billing management
◦ Insurance for Flying Study Nurses

Would you like to learn more about our individual project management for multicenter clinical trials? Then please get in touch – we look forward to hearing from you.