WellO2 is a respiratory therapy device designed to strengthen your lungs and to measure and monitor your breathing at home. The Finnish innovation is already on the market in Sweden, Norway, Denmark, South Korea and Australia, and during 2024, WellO2 will also be launched in the UK and China.
WellO2 is currently being tested in several clinical investigations, and many investigations have already been completed.
“To date, WellO2 has been studied in clinical investigations conducted by external parties. In 2021, we started the first clinical study of our own to investigate the benefits of the device for people with asthma, and that’s when we started working with Medfiles. Medfiles acted as our partner and managed the monitoring activities in the study. Our clinical investigation was successfully completed in 2022,” says Katri Lindberg, Respiratory Specialist at WellO2.
Katri works at WellO2 in an expert capacity and is responsible for the scientific content related to the device. In addition, Katri acts as the liaison with the investigators in clinical studies, ensuring good collaboration and communication. She is also responsible for finding new partners for Well02.
Comprehensive assistance in managing and monitoring clinical investigations
For WellO2’s first own clinical investigation, Medfiles acted as the CRO partner. When starting a clinical investigation for the first time, everything about them is unknown territory. For this reason, Medfiles was responsible for both applying for the research permit and designing the documents needed for the study, such as the information leaflet and the informed consent form, together with WellO2. The Medfiles project manager and CRA trained the study site staff and made sure that they had a good understanding of the basics of good clinical practice (GCP), among other things.
During the investigation, Medfiles carried out the monitoring visits at the study site. During these visits, the monitor’s job is to check that the information collected for the study matches the patient data. A big part of this is ensuring patient safety, for example by checking that all adverse events detected in the study have been reported correctly.
“This was not only WellO2’s first clinical investigation, but it was also my first. So we relied heavily on Medfiles to help us. Medfiles provided guidance on what to take into account in the different documents and the different stages of the investigation. In addition to managing the project as a whole and coordinating different parts of it, Medfiles also helped us with the practicalities and small details.”
Smooth, professional and practical support
Katri is happy with the collaboration with Medfiles and considers the practical guidance the most important benefit of the cooperation.
“Medfiles’ experts are very professional and knowledgeable, which made all aspects of the research so much easier. They provided invaluable tips on how to successfully carry out the investigation. We could always be sure that things got done and that we would be informed in good time in case there were any shortcomings that needed to be addressed. There was a sense of security in knowing that if something didn’t go right, Medfiles would step in.”
“Collaboration with Medfiles was smooth in all respects. We felt that our questions were always welcome, and we always received clear and practical guidance, helping us understand what even the things that sounded difficult meant in practice and what we should do in different situations. We were always guided in the right direction along the research path, which ensured successful completion of the investigation.”
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