More than 120 Invisio Flying Study nurses support sponsors/CROs throughout Europe in realising clinical study projects of phases 1 to 4 and in complying with international quality standards. As external service providers, they take on project-related tasks in clinics without their own research departments and test centres with high staffing levels and are the contact persons for clients, authorities, doctors, patients and relatives.
Invisio finds the right Flying Study nurse
The main tasks of Invisio include project-specific recruitment and placement, training (on-site or online) and coordination of Invisio Flying Study nurses. In addition, Invisio takes care of personnel management and other administrative activities – such as contracts and accounting.
Your advantages as a sponsor:
- Professional cooperation with medical professionals: Invisio Flying Study nurses regularly attend further training and have current IATA and GCP certificates
- Reduced workload of investigators and permanent staff in trial centres
- Permanent contact persons for study-related questions
- Faster and more reliable patient recruitment
- Better patient retention rate
- Fewer queries ensure shorter monitoring periods
- Fewer sites need to be opened due to the performance of individual test centres
- Audit security through GCP/ICH-compliant study environment
Qualifications of the Invisio Flying Study nurses
All study assistants placed by Invisio have successfully completed medical training – whether as medical-technical assistants, health and nursing staff or medical documentalists – as well as a qualifying continuing education as study nurses. They are assigned to projects according to their professional background and have a subject-specific knowledge of English. For projects abroad, only those study assistants are employed who speak the respective national language fluently or at native level.
At a glance: The services of the Invisio Flying Study nurses
- Recruitment, coordination and care of patients in trial centres/their homes
- Pre-screening before study entry and screening during the study
- Contact person for doctors, patients and relatives
- GCP/ICH-compliant preparation, documentation and archiving of relevant records and patient data – before and during the study
- Preparation and timely notification of AEs and SAEs
- Contact person for queries regarding documents and their documentation
- Ensuring communication/interaction between all project partners and authorities
- Organisation of Site Initiation Visits (SIV), Monitoring Visits (MV), Site Audit Visits (SAV) and Site Close-out Visits (SCV) in the trial centres in cooperation with sponsors/CRO
- Preparation and coordination of relevant dates and milestones
- Quality management: Review of ISF, regular checking of all relevant forms, examination of the eCRF for user-friendliness, checking the certificates/training records of persons relevant to the studies
- Work with the team: Definition of areas of competence and communication guidelines, delegation of tasks and creation of time and task schedules
- Organization: Review of storage facilities and equipment, preparation of cleaning and maintenance plans and worksheets
When should Invisio be included?
In general, Invisio enters into study projects at any time. However: The earlier Invisio is involved in the project, the sooner the study service provider can start with important steps such as the recruitment and coordination of Flying Study nurses or the creation of workflows. The differences at a glance:
Before project start:
- Selection of a team of Invisio Flying Study nurses, who are in charge of all initiated sites
- Travel and deployment planning of study assistants, taking into account holiday periods/replacement in case of illness/strong recruitment figures
- Selection of suitable test centres
- Development of responsibilities, work instructions, work processes/SOPs with the sponsor
- Training of the study assistants on-site/at the sponsor’s site/in the Invisio office
- Preparation of patient care at home
- Consultation with the centers: Presentation of the Invisio Flying Study nurses, familiarization with the systems on site, handling of data protection and confidentiality declarations, setting up system access and keys, etc.,
- In the center: Storage of CVs in the Trail Master file, entry of the study assistants in the Delegation Log
After project start:
- Personnel management (see “Before project start”)
- Comparison of the list of centres with the available Invisio Flying Study nurses
- With patient care at home: Search for study assistants in the vicinity of the site/patient’s home
- Familiarization of the Invisio Flying Study nurses with the study protocol and the procedures of the trial centre
- Consultation with the centres (see “Before project start”)
- Profitability analysis of the participating centres and recommendations based on this
Have you read them yet?
Invisio takes up the topic of Flying Study nurses in a series of articles. This is published in loose order and provides information with more detailed background texts on the benefits sponsors can derive from working with Flying Study nurses and how permanent staff in study centres can help study assistants to join the team on site.