Infrastructure covering a new process for applications for access to samples in clinical trials

Purpose and goal: ** Denna text är maskinöversatt **

In order to reverse the negative trend that fewer clinical trials are held in Sweden and instead try to increase Sweden´s attractiveness while maintaining the high quality of the examination of applications, the project aims to create a sustainable infrastructure for processing applications for access to clinical trials is adapted to EU regulations on clinical trials. The goal is to achieve a cost-effective infrastructure for a proposal for access to samples in clinical trials within three years.

Expected results and effects: ** Denna text är maskinöversatt **

The project is expected to have several positive effects for Sweden as a trial country for clinical trials. A new infrastructure for processing means faster and smoother handling of cases, which means that researchers see Sweden as an attractive country for studies. It also provides better conditions for academic studies, about 30% of applications, which often have limited resources but are very important for the development of care.

Approach and implementation: ** Denna text är maskinöversatt **

The project is carried out in five overall parts spread over a period of three years starting in mid-2021. The five parts of the project are: *) Integration for exchange of documents and process information with Läkemedelsverket *) Processtöd for handling cases between organizations *) Integration of biobank application in process for clinical trial

*) Collaborative tools for more efficient assessment of applications *) Digitalisation of the entire application process