With the systematic recruitment of study participants, Invisio Clinical Studies Consulting has created another service that promotes the implementation of national and international clinical trials in phases 1 to 4. It is aimed at sponsors and CROs and is intended to help ensure that clinical trials are completed on time and on budget and that the project runs as smoothly as possible. “We have noticed that the staff in test centers are mostly fully occupied with their daily tasks. They hardly have time to identify potential study participants or to include them in studies in the required numbers,” says Managing Director Florian Schnabel. The consequences of this lack of time could quickly become a cost factor. Because: The longer it takes to search for and include suitable patients, the more likely it is that subsequent milestones will be postponed. In addition, there is often growing pressure from competitors if the transition to the next study phase or the marketability of a product is delayed. “In these cases, it is our corporate philosophy to create customer-oriented solutions with which our target groups can overcome challenges and achieve their goals,” explains Schnabel. With this new service, the Mannheim-based company is also closing a gap in its portfolio and continuing on its path towards becoming a solution provider for the implementation of clinical study projects.
Greater visibility for study projects
The new service provides for Invisio Flying Study Nurses to act as external service providers to recruit study participants and include them in the study projects. “Our employees regularly visit the test centers and analyze the patient files. When searching for men and women with the required clinical picture, they quickly ascertain whether the existing patient base generally includes potential study participants and what causes screening failures,” says Florian Schnabel. There can be many reasons why potential participants are not a good fit. The Invisio Flying Study Nurses discuss these with the clients and discuss whether and how the inclusion and exclusion criteria can be adapted in order to carry out the study on site. If there is a fundamental lack of potential participants, this is also important feedback. From an economic point of view, it might then make more sense to continue the study project at a more promising center. “We work closely with our partner centers throughout Europe and thus have a good insight into their patient base in order to be able to react to customer requests,” says the managing director.
If required, the Invisio Flying Study Nurses also set up a GCP/ICH infrastructure in test centers, carry out clinical studies on site, and look after patients and their relatives. In other words: Sponsors and CROs can have study projects implemented from A to Z by Invisio’s trained study staff. A permanent contact person is always available on site to ensure that studies are given the necessary visibility and that important intermediate steps – such as monitoring – are achieved as smoothly as possible through professional preparation. Invisio can join a study project as a partner at any time. “The earlier we get involved, the sooner we can contribute to meeting deadlines and cost plans,” says Florian Schnabel.