Competence enhancement in clinical study: New technology for pressure monitoring of heart failure

Purpose and goal:

The goal of the project has been to verify our clinical documentation and our processes. At the start of the project, preparations were made for the upcoming clinical follow-up study. Planning and preparation took place between July 2022 to October 2022.

Within this time period, processing and further development of the results of the pilot study has also been done. After the start of the continuation study (October 2022), the project has focused on monitoring, management of data, management of clinical sites in accordance with good clinical practice and preparation for future studies.

Expected results and effects:

With the help of external competence enhancement, Acorai has been able to increase the focus on the clinical and regulatory work. We have also increased the internal competence through a competence transfer and preparations for this and future clinical studies. The competence transfer has taken place through close cooperation between consultants, the project manager and Acorai´s clinical team.

The project has led to increased employment of staff within our clinical and regulatory teams. The help we received increased the internal know-how and preparation for future studies. Approach and implementation:

July to October has handled planning and preparations for the upcoming clinical study. During this period, further development and analysis of the results of previously completed pilot studies has been done. Between October and December, the project has focused on the comprehensive clinical study, with monitoring, data management and management of clinical sites in accordance with good clinical practice.

October to December has also involved preparations for future clinical studies and a transfer of knowledge from the consultants to Acorai (e.g., discussions & materials).