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Home Care Visits

We enable you to care for your study patients at their homes

Invisio has more than ten years of experience organizing home care visits. In this way, the company contributes to the realization of clinical study projects from Phase II to Phase IV throughout Europe, even outside of trial centers.

It’s an option that benefits both patients and sponsors. In Germany, Invisio is currently the first and only service provider of clinical staff, whose quality management is certified according to DIN ISO 9001:2015.

Whether dressing changes or Doppler ultrasounds: Flying Study Nurses, physicians and investigators can perform most of the study-specific activities at the homes of their patients – in compliance with GCP and protocol. On behalf of sponsors / CROs, Invisio recruits, places and trains medical staff to perform these tasks and facilitate the participation of (immobile) patients in Phase 2 to Phase 4 clinical studies. Invisio offers this service throughout Europe. This applies to both study projects that take place at one trial center and multicenter studies at several locations. For projects abroad, Invisio often works together with a local study coordinator.

In general, home care visits are possible for almost any indication.

  • Cardiology
  • Dermatology
  • Oncology and Hematology
  • Allergology
  • Neurology
  • Medical Devices
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How do home care visits work?

They can be briefly summarized as follows: Flying Study Nurses, physicians and/or investigators visit the already recruited study participants at home. They first discuss whether the patients have any questions or have experienced any side effects since the last visit. This is followed by study-specific work, such as taking blood samples or processing specimens. Documentation activities are performed by medical staff working from home or at the trial center.

Patient care

  • Coordination of home care visits
  • Logistics: shipping of blood samples, medicines, small equipment, etc.
  • Screenings: before study entry and during the study
  • Implementation of the study protocol including follow-up
  • Contact persons and guides for patients and their families

Data management

  • Data protection and study-compliant documentation, recording and archiving of all patient data, events (incl. SUSARs) and relevant documents
  • Preparation and timely notification of AEs and SAEs
  • Contact person for sponsors /CROs for questions regarding documentation

Studienkoordination

  • Administration: registration and randomization of study participants, preparation of documents for authorities, responsibility for investigator and study folders, contract tracking
  • Organization: scheduling and preparation of visits, initiation of studies
  • Support of pre-study visits, initiations of studies and participation in investigator meetings
  • Cost-benefit analysis

How can you benefit from Home Care Visits?

It can be positive for everyone involved if study participants are cared for at home. We have compiled some examples of the advantages for patients and sponsors:

Advantages as a sponsor

  • Qualified Flying Study Nurses, physicians and investigators relieve the internal study staff
  • More study participants: active patient recruitment; participants can be recruited from a larger catchment area because the medical professionals are decentralized
  • Fewer patient withdrawals: reduced number of visits to trial centers increases the chance that patients will continue participating in clinical studies longer; in addition, patient satisfaction may increase because there is a fixed caregiver
  • Home care visits are even safe to implement under pandemic conditions
  • Invisio quality management: certified according to DIN ISO 9001:2015

Benefits for patients

  • No need to travel to the trial center - except for examinations requiring large medical equipment, such as an MRI
  • Inclusion is also possible in clinical study projects that are realized in distant study centers
  • Individual arrangement of appointments increase the compatibility of work with participation in the study
  • Medical staff focus one hundred percent on one patient during the visit
  • For children, receiving care in familiar surroundings can be more pleasant

Would you like to learn more about our Flying Study Nurses?

We provide detailed information about the qualifications and range of services offered by our Flying Study Nurses on our services page of the same name. We have also published several articles on their work in our news section outlining the benefits that sponsors / CROs and internal staff at trial centers can reap by working with study assistants.

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.

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Invisio Clinical Studies Consulting GmbH
Email: info@invisio.eu
Phone: +49 (0)621 / 180 685 940
Fax: +49 (0)621 / 180 685 949

Headquarter Mannheim
Harrlachweg 18
68163 Mannheim
Germany

Office Berlin
Kurfürstendamm 14
10719 Berlin
Germany

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