“For the past year and a half, we have noticed that the demand for flying study nurses as well as for expert help in the implementation of clinical study projects has increased throughout Europe. To be able to meet these customer requirements, we have taken the next step and expanded our network to include international partners. Our goal is to increase the number of phase 1 to 4 clinical studies in the countries within the European Union,” Invisio CEO Florian Schnabel commented. For the coming year, the Mannheim-based study service provider expects to support 60 to 100 study centers across the EU in clinical study projects.
In which countries can Invisio implement clinical study projects?
Invisio is already regularly active in Germany, Austria and Switzerland. In addition to the DACH region, the company can also manage projects in Belgium, the Netherlands, Luxembourg, France, Spain, Portugal, Italy, Croatia, Hungary, the Czech Republic, Slovakia, Poland, Finland, Sweden, Denmark, the United Kingdom and Ireland.
What services does Invisio offer outside Germany?
The focus is on project management and supervision of clinical multi-center studies in phases 1 to 4. In other words, Invisio implements parallel international study projects in different European countries. The Invisio Flying Study Nurses work closely with the trial centers and the Principal Investigator (PI) on site and support them in implementing the study procedures and requirements in accordance with GCP/ICH guidelines, as well as in handling the projects on schedule and with rapid patient recruitment. Furthermore, they are actively involved in optimizing patient recruitment.
How does Invisio ensure the quality of its services abroad?
Invisio has transferred its internal structures and guidelines to all countries in which it is active in order to meet its own quality and safety requirements. This includes, as a matter of principle, only employing trained study assistants who – regardless of their location – are bound by the same internal guidelines and Standard Operating Procedures (SOPs). In addition, Invisio prepares project-specific SOPs and draws up concrete work instructions with the respective sponsors in advance, which prepare the Invisio Flying Study Nurses in the best possible way for the required activities and also include solution proposals for unexpected situations. As a rule, sponsors involve a Clinical Research Organisation (CRO) as a supervisory body, which provides early warning of potential challenges.
In order to make the cooperation in the trial centers and the care of the patients as smooth as possible and to avoid misunderstandings, all Invisio Flying Study Nurses will speak the respective national language fluently or at native language level.
How does Invisio position itself to create the additional workload?
Internally, Invisio is broad enough to cope with the tasks of daily business. For individual tasks, the core team nevertheless works together with external partners. These include project managers who, if required, support the realization of clinical studies in other European countries. In these cases Invisio makes sure that the employees have the appropriate language skills. In addition, Invisio cooperates with several internationally active consulting firms which assist the company in the search for suitable specialists.