In the second part of the article series Clinical Studies with Flying Study Nurses, he explains how the services of the Mannheim-based study service provider differ before and after the start of the project.
“Study assistants work flexibly and can therefore enter clinical studies at any time,” says Florian Schnabel, Managing Director of Invisio Clinical Studies Consulting. The core business of the Mannheim-based study service provider includes placing trained Flying Study Nurses in national and international phase 1 to phase 4 clinical studies. Nevertheless, Schnabel recommends planning the use of Flying Study Nurses at an early stage and not only bringing them on board once the implementation process is lagging — or even at a stillstand. “The earlier professional Flying Study Nurses relieve the medical staff and take over the coordination of the study on site, the sooner they can start the project and/or work through open issues,” explains the Managing Director. From his point of view, the cooperation of external study staff offers further advantages such as: compliance with international quality standards; a higher patient recruitment rate; minimization of the risk of unscheduled costs due to delays in the flow of the project; no downtime due to the use of substitute personnel; intensive patient care; the control of the study by a central on-site contact person.
Invisio services before the project starts
Florian Schnabel sums up the services Invisio provides when the company is involved before the project starts as follows: “From our network with German and European trial sites, we suggest the ones with the most promising recruitment rates to our clients. Then, within a few days, we put together a team of Invisio Flying Study Nurses to oversee the sites.” In addition, Invisio plans the assignments and travel of external study personnel in consultation with the trial sites and supports them in implementing the requirements for data protection and confidentiality.
In order to avoid overlapping work and misunderstandings, Invisio defines the responsibilities in the project in advance with its customers. Together with them, it develops project-specific work instructions and workflows/SOPs according to which the Invisio Flying Study Nurses are trained. The training sessions take place either directly at the trial site, at the respective sponsor’s, or at Invisio in Mannheim.
In addition, the study service provider accompanies the onboarding process of the Invisio Flying Study Nurses in the trial sites and, in consultation with the sponsor, prepares patient care at home. “For example, we ensure that even in such cases, our study assistants are equipped with the necessary protective gear such as gowns, disinfectants, and masks. We also provide practical solutions for the transport and storage of medicines as well as the logistics and processing of samples,” says Florian Schnabel.
Invisio services after the project starts
In general, Invisio also places study staff if the projects have already started. “In these cases, we also take over the recruiting and resource planning, familiarize the Invisio Flying Study Nurses with the specifications and procedures at the trial site, and coordinate with them,” explains Florian Schnabel. “At the customer’s request, we can also analyze how economically the participating sites are working with regard to the study project and, if necessary, make recommendations to achieve optimization potential.”